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Biogen
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Biogen
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Biogen Inc. is an American multinational biotechnology company based in Cambridge, Massachusetts, United States specializing in the treatment of neurological diseases.[1] The company's primary products are dimethyl fumarate (Tecfidera), diroximel fumarate (Vumerity), interferon beta-1a (AVONEX), peginterferon beta-1a (Plegridy), and natalizumab (Tysabri), all for the treatment of multiple sclerosis (collectively 45% of 2024 revenues); nusinersen (Spinraza) for the treatment of spinal muscular atrophy (16.2% of 2024 revenues); omaveloxolone (Skyclarys) for the treatment of Friedreich's ataxia (4.0% of 2024 revenues); tofersen (Qalsody) for the treatment of ALS; and dimethyl fumarate (Fumaderm) for the treatment of severe plaque psoriasis.[1] The company also produces 5 biosimilars (8.2% of 2024 revenues) and has collaborations with Genentech for several drugs (18.1% of 2024 revenues).[1]

Key Information

The company is ranked 424th on the Fortune 500[2] and 845th on the Forbes Global 2000.[3]

History

[edit]

Biogen was founded in 1978 in Geneva as Biotechnology Geneva by several prominent biologists, including Kenneth Murray from the University of Edinburgh, Phillip Allen Sharp from the Massachusetts Institute of Technology, Walter Gilbert from Harvard University (Gilbert served as CEO during the start-up phase of Biogen), Heinz Schaller from the University of Heidelberg, and Charles Weissmann from the University of Zurich (Weissmann contributed the first product interferon alpha).[4][5] Gilbert and Sharp were subsequently honored with Nobel Prizes: Gilbert was recognized in 1980 with the Nobel Prize in Chemistry for his understanding of DNA sequencing[6] and Sharp received the Nobel Prize in Physiology or Medicine in 1993 for his discovery of split genes.[7]

In 2003, Biogen merged with San Diego, California-based IDEC Pharmaceuticals (formed in 1985 by University of California-San Diego's physicians and immunologists Ivor Royston and Robert E. Sobol, San Diego bio entrepreneur Howard Birndorf, and Stanford University cancer researchers Ron Levy and Richard Miller) and adopted the name Biogen Idec.[8][9] After the merger, Biogen Idec became the 3rd largest Biotechnology company in the world.[10]

Following shifts in research core areas, the company has since shortened its name, reverting to simply Biogen.[11]

In May 2006, the company announced it would acquire cancer specialist, Conforma Therapeutics for $250 million.[12] Later in the same month, the company announced its intention to acquire Fumapharm AG, consolidating ownership of Fumaderm and BG-12, an oral fumarate, which was being studied for the treatment of multiple sclerosis and psoriasis.[13]

In January 2007, the company announced it would acquire Syntonix Pharmaceuticals for up to $120 million, gaining Syntonix's lead product for hemophilia B as well as the technology for developing inhalable treatments.[14][15][16]

In 2008, two new brain infection cases from Tysabri users surfaced in Europe that raised international concern about Tysabri and its effects with the progressive multifocal leukoencephalopathy (PML) brain condition. Biogen is one of the drug's producers.[17]

In 2011, Biogen announced that its drug Fampyra received conditional marketing approval. Under the conditional approval, Biogen agrees to provide additional data on the long-term benefits and safety of Fampyra.[18]

On December 10, 2012, Biogen announced its global collaboration agreement with Isis Pharmaceuticals to develop and research antisense drugs to treat neurological and neuromuscular diseases.[19]

In February 2013, Bloomberg broke the news that Biogen was planning to pay Elan $3.25 billion for the full rights to Tysabri, used to treat multiple sclerosis.[20]

In 2013, Biogen was the first U.S.-based biotechnology company to appear on the Dow Jones Sustainability World Index.[21]

In January 2015, the company announced that it would acquire Convergence Pharmaceuticals for up to $675 million, with the acquisition aiming to accelerate the development of Convergence's pipeline, in particular CNV1014802 – a Phase II small molecule sodium channel blocking candidate.[22] In October 2015, the company announced that it would lay off 11% of its workforce, effective immediately.[23]

On May 3, 2016, Biogen announced plans to spin off its hemophilia business, known as Bioverativ as an independent publicly traded company. Bioverativ offered two hemophilia drugs in 2016, Alprolix and Eloctate, and plans on developing its Hemophilia-focused goals.[24]

In 2016, Biogen released Spinraza (nusinersin), a treatment for Spinal Muscular Atrophy. The drug is among the most expensive treatments available, with a price of $750,000 for the first year of doses, and $375,000 for each subsequent year and likely for the rest of a patient's life.[25] While there still isn't a cure, Spinraza significantly improves the quality of life in infants and adults.

In 2017, Biogen announced that its drug Fampyra converted from conditional marketing authorization to standard marketing approval. EU multiple sclerosis (MS) patients use Fampyra to improve walking.[18]

In February 2020, Biogen and Sangamo Therapeutics announced a global licensing deal to develop compounds for neuromuscular and neurological diseases.[26]

In September 2020, Biogen Inc. made a $10 million deposit in OneUnited Bank to provide more capital to fund home loans and commercial development in Black communities.[27] In November, the company announced it would acquire a $650 million stake in Cambridge-based Sage Therapeutics and make an upfront payment of $875 million, in order to jointly develop depression treatments.[28]

In July 2023, Biogen acquired Reata Pharmaceuticals, headquartered in Plano, Texas, for nearly $6.5 billion.[29] That month, the company also cut 1,000 jobs, or 11% of its workforce.[30]

In May 2024, Biogen acquired Human Immunology Biosciences (HI-Bio) for $1.15 billion.[31]

In July 2025, the company announced a $2 billion investment in manufacturing facilities in Research Triangle Park.[32][33]

In September 2025, the company agreed to acquire Alcyone for $85 million.[34][35]

Aducanumab

[edit]
Main article: Aducanumab

In 2007, the company reached a licensing agreement with Neurimmune, a spin-off from the University of Zurich, for the Alzheimer's disease drug, Aducanumab, developed by this Swiss company. Later, Neurimmune sold its rights for license fees for $200 million to Biogen.[4]

In December 2014, Biogen announced that Aducanumab for Alzheimer's treatment was preparing to go through a late-stage trial of its experimental Alzheimer's disease treatment after the medication dramatically improved cognition and reduced brain plaque levels in early-stage study.[36]

In March 2015, Aducanumab became the first experimental Alzheimer's treatment to show significant results in regard to slowing down cognitive decline and reducing brain-destroying plaques.[37] In July 2015, Biogen initiated two late-stage studies called ENGAGE and EMERGE, which will assess Aducanumab in adults with early Alzheimer's disease.[38]

In 2016, Aducanumab decreased amoyloid-beta in the brains of people with early-stage Alzheimer's disease, according to a report published in Nature on August 31, 2016.[39] On March 21, 2019, Biogen announced that the Phase 3 clinical trials of Aducanumab were halted.[40] Biogen announced it would acquire Nightstar Therapeutics for $25.50 per share ($800 million in total). Nightstar focused on adeno-associated virus based gene-therapies for inherited retinal disorders.[41][42] With a setback in their drug research, Biogen's shares fell sharply that same month.[43] It ended the trial of Aducanumab, which it was making along with Eisai.[44] In October 2019, however, they announced that they would pursue FDA approval together with Eisai.[45]

On October 22, 2019, despite two Phase 3 clinical trials being previously halted for futility, Biogen announced its plan to submit for FDA's approval of Aducanumab.[46] In May 2020, Biogen wrapped up construction on a state-of-the-art facility in Solothurn, Switzerland, which will produce Aducanumab by late 2021, alongside its North Carolina manufacturing facility. The monoclonal antibody, co-developed with Eisai, attracted considerable interest from biotech investors when Warren Buffett's Berkshire Hathaway bought 648,447 Biogen shares at a combined value of $192.4 million.[47]

On July 8, 2020, Biogen and Eisai announced that both companies had together successfully submitted for Aducanumab's FDA regulatory and marketing approval.[48]

On June 7, 2021, the FDA gave accelerated approval to Aducanumab under the name Aduhelm,[49] which proved to be controversial.[50][51] The drug was priced at $56,000 US dollars per year, but it was not covered by many insurers as they awaited further proof that the drug was effective.[52] The US Government did not subsidise it outside clinical trials.[53] According to the FDA's website, the drug was proven to reduce amyloid-beta plaques in the brain, which was likely to benefit patients. The FDA has stated that if the post-approval trial did not indicate that Aduhelm works, the drug may be taken out of the market.[54]

Biogen abandoned the drug in January 2024, for financial reasons.[55]

Bioverativ

[edit]

In January 2017, the company completed the corporate spin-off its hemophilia drug business (Eloctate and Alprolix) into a public company, later named Bioverativ. It was acquired by Sanofi in 2018 for $11.6 billion.[56][57][58][59][60][61][62]

Acquisition history

[edit]

The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list):

  • Biogen
    • Biogen IDEC
      • Biogen (Est 1978)
      • IDEC Pharmaceuticals
    • Conforma Therapeutics (Acq 2006)
    • Fumapharm AG (Acq 2006)
    • Syntonix Pharmaceuticals (Acq 2007)
    • Convergence Pharmaceuticals (Acq 2015)
    • Nightstar Therapeutics (Acq 2019)
    • Reata Pharmaceuticals (Acq 2023)
    • Human Immunology Biosciences (HI-Bio) [31]

Conference during COVID-19 pandemic that led to 300,000 cases

[edit]
See also: COVID-19 pandemic

On March 5, 2020, Biogen reported that three individuals who met with their employees at a conference in Boston had tested positive for COVID-19 the previous week.[63] On March 6, public health officials reported five new cases associated with the Biogen leadership meeting[64][65] and by March 9, Massachusetts health officials had announced 30 new presumptive COVID-19 cases, all connected to the Biogen conference.[66][67] Researchers first estimated that the conference would be linked to over 20,000 of the state's COVID-19 cases.[68][69] Researchers later estimated that up to 300,000 cases worldwide had been caused by the Biogen conference, including 1.6% of all U.S. cases of COVID-19.[69]

Finances

[edit]
Year Revenue
in mil. USD$ 		Net income
in mil. USD$ 		Total Assets
in mil. USD$ 		Price per Share
in USD$ 		Employees
2005 2,423 161 8,382 39.89
2006 2,683 218 8,553 42.39
2007 3,172 638 8,629 52.16
2008 4,098 783 8,479 51.09
2009 4,377 970 8,552 45.11
2010 4,716 1,005 8,092 51.95
2011 5,049 1,234 9,050 84.78
2012 5,516 1,380 10,130 125.83
2013 6,932 1,862 11,863 198.43 6,850
2014 9,703 2,935 14,315 293.10 7,550
2015 10,764 3,547 19,505 324.99 7,350
2016 11,449 3,703 22,877 258.27 7,400
2017 12,274 2,539 23,653 289.19 7,300
2018[70] 13,453 4,431 25,289 7,800
2019[71] 14,378 5,889 27,234 7,400
2020[72] 13,445 4,001 24,619 9,100
2021[73] 10,981 1,556 23,877
2022[73] 10,173 3,046 24,554
2023[73] 9,835 1,161 26,844

Products

[edit]
Therapy Indication (In United States unless otherwise noted) Year Approved (US) Year Approved (EU) Additional Information
LEQEMBI™ [(lecanemab-irmb)] Indicated for patients with mild cognitive impairment or mild dementia stages of Alzheimer's disease. 2023 (pending) Biogen and Japanese Eisai are collaborators in the development and commercialization of LEQEMBI.[74]
ADUHELM™ [(aducanumab) Human Immunoglobulin Gamma 1 (IgG1) monoclonal antibody] Indicated for all stages of Alzheimer's disease, including patients with confirmed presence of amyloid pathology and mild cognitive impairment or mild dementia. 2021 (pending) U.S. FDA accelerated approval.

Biogen and Japanese Eisai are collaborators in the development and commercialization of ADUHELM.[75]

ALPROLIX™ [Coagulation Factor IX (Recombinant), Fc Fusion Protein] Control and prevention of bleeding episodes, perioperative management and routine prophylaxis in adults and children with hemophilia B 2021 1993 Also approved in Canada and Australia.

Biogen and Swedish Orphan Biovitrum (Sobi) are collaborators in the development and commercialization of ALPROLIX.[76]

AVONEX® (interferon beta-1a) Relapsing forms of multiple sclerosis 1996 1997 Includes the AVONEX PEN auto-injector and the AVOSTARTGRIP titration kit approved in the U.S. in 2012.[77]
ELOCTATE™ [Antihemophilic Factor (Recombinant), Fc Fusion Protein] Control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia A 2014 1999 Biogen and Swedish Orphan Biovitrum (Sobi) are collaborators in the development and commercialization of ELOCTATE.[78]
FAMPYRA (prolonged-release fampridine tablets) Multiple sclerosis (Walking ability) 2010 2011 Marketed by Biogen in markets outside of the United States.

Commercialized in the United States as AMPYRA (dalfampridine) Extended Release Tablets, by Acorda Therapeutics.[79]

FUMADERM (fumaric acid esters) Psoriasis German use 1994 (Germany only) Approved in Germany.

Acquired in acquisition of Fumapharm AG in 2006.[80]

GAZYVA (obinutuzumab) Chronic lymphocytic leukemia 2013 2014 The first medicine approved with the FDA's Breakthrough Therapy Designation and is also currently in Phase 3 trials for NHL and diffuse large B-cell lymphoma.

Currently commercialized in the United States by Genentech, a wholly owned subsidiary of Roche.[81]

IMRALDI (adalimumab) Immunosuppressive drug to treat autoimmune disorders such as inflammatory bowel disease 2019 2018 Biosimilar of AbbVie's Humira.[82][83]
SPINRAZA (nusinersen) Spinal muscular atrophy (SMA) 2016 2017 The first drug approved for the treatment of spinal muscular atrophy, developed in collaboration with Ionis Pharmaceuticals.[84][85]
PLEGRIDY (peginterferon beta-1a) Relapsing forms of multiple sclerosis 2014[86] 2014[87]
RITUXAN (rituximab) Non-Hodgkin lymphoma (NHL)

Anti-TNF Refractory Rheumatoid Arthritis

ANCA-Associated Vasculitis

Chronic lymphocytic leukemia

1997[88]

2006[89]

2011[90]

1998 (as MabThera) The first monoclonal antibody for cancer developed by IDEC, prior to merging with Biogen.

Currently commercialized by Roche and its subsidiary, Genentech.

TECFIDERA (dimethyl fumarate) Relapsing forms of multiple sclerosis 2013[91] 2014[92]
TYSABRI (natalizumab) Relapsing-remitting multiple sclerosis 2004 Re-introduced in 2006 2006 Full rights purchased from partner Elan in 2013.[93]

Pipeline

[edit]

Investigational MS medicines:

  • Daclizumab High-Yield Process (DAC HYP): is being developed as a potential once-monthly subcutaneous injection in the treatment of relapsing-remitting multiple sclerosis (RRMS). DAC HYP is being developed in collaboration with Abbvie, Inc. In June 2014, the companies announced positive top-line results from the Phase III DECIDE clinical trial, where DAC HYP demonstrated superiority over interferon beta-1a in annualized relapse rate.[94]
  • Anti-LINGO-1 (BIIB033) (Opicinumab): is the first candidate being investigated for its potential to remyelinate and repair neurons damaged by MS. Phase II trials were conducted in 2016 but failed to reach their goals.[95]

Biogen has several candidates in Phase 1 and 2 clinical trials in neurodegenerative and immunological diseases including MS, neuropathic pain, spinal muscular atrophy and lupus nephritis:

  • Phase 2a: anti-LINGO-1 molecule (Opicinumab) in acute optic neuritis
  • Phase 2b: anti-TWEAK monoclonal antibody in lupus nephritis
  • Phase 2a: STX-100 in patients with idiopathic pulmonary fibrosis
  • Phase 2: Neublastin for neuropathic pain in 2013
  • Phase 1/2: BIIB067 (ISIS-SOD1Rx) for amyotrophic lateral sclerosis, in collaboration with Ionis

Biogen also has several development agreements in place with Ionis Pharmaceuticals to collaborate to leverage antisense technology in advancing the treatment of neurological disorders.[96]

In February 2012, Biogen formed a joint venture with Samsung, Samsung Bioepis. Samsung acquired Biogen's interest in the venture in January 2022 for up to $2.3 billion.[97]

In early 2014, Biogen entered into an agreement with Eisai to jointly develop and commercialize two of their candidates for Alzheimer's disease, which have the potential to reduce Aβ plaques that form in the brains of patients, as well as to slow the formation of new plaques, potentially improving symptoms and suppressing disease progression.[96]

Biogen also has since 2015 an agreement with AGTC to develop gene therapy for several genetic diseases, including X-linked retinoschisis (XLRS) and X-linked Retinitis pigmentosa (XLRP) ophthalmologic diseases. Biogen paid AGTC $124 million, including an equity investment of $30 million, and offered up to $1.1 billion in future milestone payments.[98]

In March 2019, Biogen halted Phase 3 trials of Alzheimer's disease drug Aducanumab after "an independent group's analysis show[ed] that the trials were unlikely to 'meet their primary endpoint.'"[99] However, in October 2019 they reversed their plans and said that they would be pursuing US FDA approval for Aducanumab. The reversal came after Biogen said a new analysis of a larger patient pool showed promising results.[45] In July 2020, Biogen completed submission of a Biologics license application (BLA) to the FDA for review, and requested accelerated review.[100] However, an advisory panel for the FDA voted against approval of this drug.[101] On June 7, 2021, the FDA granted approval of Aducanumab for the treatment of Alzheimer's disease. Aducanumab was approved using the accelerated approval pathway, and Biogen will be required to conduct a post-approval clinical trial to verify clinical benefit for continued approval.[102]

Lawsuits

[edit]

In September 2022, Biogen agreed to pay $900 million to the U.S. federal government, states, and a whistleblower. Biogen had bribed doctors between 2009 and 2014 to increase prescriptions of Avonex, Tysabri, and Tecfidera (all for multiple sclerosis).[103]

See also

[edit]

References

[edit]
[edit]
Revisions and contributorsEdit on WikipediaRead on Wikipedia

Biogen

View on Grokipedia
from Grokipedia

Biogen Inc. is a multinational biopharmaceutical company founded in 1978 by a group of scientists including Nobel laureate Walter Gilbert, initially in Geneva, Switzerland, and headquartered in Cambridge, Massachusetts, that develops and commercializes therapies primarily for neurological, neurodegenerative, and rare diseases. The company pioneered applications of recombinant DNA technology in biotechnology and has focused on treatments for conditions such as multiple sclerosis (MS), spinal muscular atrophy (SMA), and hemophilia. Biogen's key products include Avonex, the first recombinant approved for relapsing MS in 1996, Tecfidera () for MS approved in 2013, and Spinraza (), the first approved treatment for SMA marketed in partnership with . The firm received the U.S. National Medal of Technology and Innovation in 1998 for its contributions to . Biogen has also advanced efforts, achieving carbon neutrality in 2015 and 100% My Green Lab certification across its laboratories by 2023. A notable controversy arose from the 2021 FDA accelerated approval of Aduhelm (aducanumab) for , granted despite unanimous rejection by the agency's advisory committee due to ambiguous results showing plaque reduction but no clear cognitive benefits, and broader labeling than studied populations. Congressional investigations revealed FDA deviations from protocols, including improper meetings with Biogen executives, eroding trust in the approval process. Biogen discontinued Aduhelm in January 2024 amid low sales, limited Medicare coverage, and emergence of rival therapies with stronger evidence.

History

Founding and Early Innovations (1978–1990s)

Biogen was founded in 1978 in , , under the name Biotechnology Geneva by a of prominent molecular biologists, including Nobel laureates of and Phillip A. Sharp of MIT, as well as Charles Weissmann, Heinz Schaller, and Kenneth Murray. The company's inception capitalized on emerging technology, aiming to produce therapeutic proteins at scale for medical applications, positioning it among the earliest global firms dedicated to this approach. Gilbert, who won the 1980 for methods, served as the initial chairman, emphasizing a research-centric model focused on licensing innovations to larger pharmaceutical partners rather than direct manufacturing. In the early 1980s, Biogen expanded its operations by establishing an international research and development network across , including facilities in Zurich, , , and , to accelerate efforts. The company relocated its U.S. headquarters to , in 1982, leveraging proximity to academic hubs like MIT and Harvard for talent and collaboration. A pivotal early innovation was the development of recombinant alpha , with the gene cloned in late 1979 by Weissmann's team; this marked one of the first successful applications of bacterial expression systems for mammalian proteins. In 1984, Biogen secured the first patent in the U.S. or for a recombinant DNA-derived product, covering this production process. Licensing agreements enabled commercialization of alpha interferon, with Schering-Plough gaining rights; the drug received approval for sale in starting in 1985 (initially in Ireland) and became Biogen's first revenue-generating product by 1986, treating conditions like and later . Building on this, Biogen advanced recombinant beta interferon in the late and early 1990s, culminating in the 1996 FDA approval of Avonex (), the company's proprietary treatment for relapsing-remitting , which demonstrated reduced relapse rates in clinical trials and established Biogen's foothold in . These efforts underscored Biogen's role in validating as a viable platform for biologics, though early financial challenges persisted until licensing royalties scaled in the late , yielding the firm's first profit of $3.2 million in 1989.

Product Commercialization and Growth (2000s)

In the early 2000s, Biogen's primary revenue driver remained Avonex (), its therapy approved in 1996, with U.S. and international sales reaching $761 million in 2000, a 23% increase from $621 million in 1999, fueled by expanded patient access and manufacturing scale-up that supported a fivefold production volume rise from 1996 to 1999. Total company revenues grew to $926.5 million that year, up 17% from 1999, though dependence on Avonex—accounting for over 80% of sales—exposed Biogen to risks from impending generic competition post-2003 Act expiration. To diversify and accelerate growth, Biogen merged with IDEC Pharmaceuticals in a $6.8 billion all-stock transaction announced on June 23, , with IDEC acquiring Biogen at a 1.15:1 share exchange ratio, forming Biogen Idec as the third-largest U.S. firm by . The merger, completed on November 12, , integrated IDEC's portfolio, notably enhancing commercialization of Rituxan (rituximab), a copromoted with ; Biogen's share of U.S. Rituxan operating profits reached $419.2 million in , rising to $469.5 million in 2004 amid expanding indications. This combination drove 19% revenue growth in , with Avonex U.S. sales at $800 million and international at $368 million (pro forma). A pivotal commercialization milestone occurred with Tysabri (natalizumab), co-developed with Elan Corporation and approved by the FDA on November 23, 2004, for relapsing based on phase 3 trials showing superior efficacy over Avonex in reducing relapses. Initial launch generated strong early demand, but sales were voluntarily suspended in February 2005 after two (PML) cases linked to JC virus reactivation, halting U.S. marketing and clinical trials. Following extensive safety reviews, including a risk evaluation and mitigation strategy, the FDA reapproved Tysabri on June 5, 2006, under TOUCH prescribing conditions, enabling resumed commercialization and contributing to subsequent MS portfolio expansion. Overall, these efforts propelled Biogen Idec's revenues to $2.68 billion in 2006, an 11% increase from $2.42 billion in 2005, with Avonex sales climbing 11% to $1.71 billion and Rituxan U.S. net sales exceeding $2 billion annually by mid-decade, underscoring merger synergies and focus despite Tysabri's setback.

Strategic Realignments and Challenges (2010s–Present)

In the early 2010s, Biogen pursued aggressive expansion beyond its (MS) franchise through acquisitions and pipeline diversification, including the 2012 purchase of Fumapharm for $1.26 billion to secure Tecfidera (), which launched in 2013 and drove peak sales exceeding $4.5 billion annually by 2019. However, looming patent expirations for legacy drugs like Avonex () in 2018 and Rituxan biosimilar competition prompted early strategic reviews, leading to cost-control measures and a pivot toward high-risk, high-reward areas like , where Biogen invested heavily in anti-amyloid therapies starting with trials showing preliminary efficacy signals in 2015. The 2021 accelerated FDA approval of Aduhelm () on June 7 marked a pivotal but contentious realignment, based on surrogate biomarker data from the EMERGE trial indicating plaque reduction despite mixed cognitive outcomes and a failed companion study (ENGAGE), with the agency overriding its advisory committee's rejection amid allegations of . Priced initially at $56,000 per year, the drug faced immediate backlash over unsubstantiated efficacy claims, limited Medicare coverage restricting access to clinical trials, and sales far below the projected $3 billion by 2023—peaking at under $3 million in 2022—exacerbating investor skepticism and contributing to CEO Michel Vounatsos's in November 2021. This debacle, coupled with a U.S. investigation into Biogen's promotional tactics, forced a strategic retreat, culminating in the January 2024 discontinuation of Aduhelm development and transfer of rights to Neurimmune, freeing resources amid ongoing legal and ethical scrutiny. Under new CEO Christopher Viehbacher, appointed in 2022, Biogen initiated sweeping restructurings to address MS revenue erosion from biosimilars and generics—Tecfidera sales dropped over 50% post-patent loss in 2020—announcing 1,000 layoffs (11% of workforce) in July 2023 and further R&D cuts in January 2025 affecting 30-50% of its 500-person research team, shifting emphasis to external partnerships and late-stage assets in , rare diseases, and Alzheimer's alternatives like Leqembi (, co-developed with and launched in 2023). These moves, including discontinuation of AAV programs in September 2025 with 20 staff impacted, aimed to streamline operations and prioritize bolt-on acquisitions over megadeals, though challenges persist with Leqembi sales growth lagging forecasts due to reimbursement hurdles and adherence issues, alongside broader pipeline setbacks in and . By 2025, Biogen's strategy crystallized around a "new Biogen" narrative, focusing on offsetting MS declines—down years of erosion—with diversified launches, yet analyst downgrades highlight risks from execution delays and competitive pressures in neurodegeneration.

Leadership and Governance

Key Executives and CEOs

Christopher A. Viehbacher has served as Biogen's President and Chief Executive Officer since November 14, 2022, when he succeeded Michel Vounatsos. Prior to Biogen, Viehbacher was CEO of from 2008 to 2014, where he oversaw expansions in emerging markets and acquisitions including for $20.1 billion in 2011. Key current executives include Susan H. Alexander as Chief Legal Officer, responsible for legal, compliance, and government affairs; Robin Kramer as , managing financial strategy and operations; Priya Singhal, M.D., M.P.H., as Head of Development, overseeing clinical development pipelines; and , M.D., M.P.H., M.B.A., as and Head of Medical Affairs. Additional senior leaders comprise Alisha A. Alaimo as President and Head of , directing U.S. and Canadian commercial activities, and Alfred W. Sandrock, Jr., as Executive Vice President of , leading scientific innovation efforts. Biogen's CEO history reflects shifts amid product launches, mergers, and strategic challenges:
CEOTenure
James L. Vincent1985–2000
James C. Mullen2000–2010
George A. Scangos2010–2016
Michel Vounatsos2017–2022
Christopher A. Viehbacher2022–present
Vincent initiated restructuring in the 1980s to commercialize early biologics like interferon. Mullen led the 2003 merger with IDEC Pharmaceuticals, forming Biogen Idec and advancing multiple sclerosis treatments. Scangos focused on neurology expansion, including Spinraza approval in 2016, before departing amid board transitions. Vounatsos navigated Aduhelm's 2021 approval and subsequent Medicare restrictions, culminating in his exit.

Board Composition and Strategic Decisions

Biogen's consists of 10 independent members plus CEO Christopher A. Viehbacher, chaired by Caroline Dorsa, a former executive at and with financial expertise. The board features strong representation in , , and finance, with four designated financial experts and several physicians experienced in . Key members include Maria C. Freire (biotech CEO and foundation leader), William A. Hawkins (former CEO), Susan Langer (former Alnylam executive), Jesus B. Mantas (healthcare investor), Lloyd B. Minor, M.D. (Dean of Stanford School of Medicine), Sir Menelas Pangalos, Ph.D. (former R&D head), Monish Patolawala (former CFO at Biogen and ), Eric K. Rowinsky, M.D. (oncology drug developer), and Stephen A. Sherwin, M.D. (former executive).
MemberKey BackgroundCommittee Roles
Caroline D. DorsaPharma finance and operationsChair, ;
Maria C. FreireBiotech leadership and Compensation;
William A. Hawkins CEO; ;
Susan LangerRNAi therapeutics executiveCompensation
Jesus B. MantasHealthcare Chair, Compensation
Lloyd B. Minor, M.D.Otolaryngology and med school dean
Menelas Pangalos, Ph.D.Biopharma R&D executiveCompensation
Monish PatolawalaPharma Chair, ;
Eric K. Rowinsky, M.D.Cancer Compensation;
Stephen A. Sherwin, M.D. and executive;
The board operates through three standing committees: (chaired by Patolawala), (chaired by Mantas), and (chaired by Dorsa), which oversee financial reporting, executive pay, and director nominations, respectively. Recent board changes reflect efforts to bolster scientific and strategic capabilities amid pipeline challenges. In June 2023, directors Alexander Denner, William Jones, and did not stand for re-election, with Susan Langer added and two seats left vacant to prioritize quality over size, signaling a shift from conservative oversight. In September 2024, Lloyd Minor and Menelas Pangalos were appointed effective October 1, 2024, and January 1, 2025, respectively, to inject R&D expertise from academia and industry. Caroline Dorsa succeeded Stelios Papadopoulos as chair around this period, following his departure. The board has influenced pivotal strategic decisions, particularly in response to the Aduhelm Alzheimer's drug controversy. The 2021 accelerated FDA approval, despite advisory committee rejection and internal data disputes, drew intense for high ($56,000 annually) and limited , eroding trust and contributing to a 2022 CEO transition from Michel Vounatsos to Viehbacher. Board actions, including curtailing Vounatsos's influence, underscored tensions over risky approvals. Under Viehbacher, the board endorsed , discontinuing Aduhelm in January 2024 after minimal uptake and refunding U.S. payers, while focusing on staples like therapies and rare diseases. 2023-2024 refreshes have aligned with a more aggressive posture, including pursuits like the unsolicited Sage Therapeutics bid in late 2024, rejected by Sage's board in January 2025. These moves aim to restore credibility through empirical R&D focus rather than accelerated regulatory gambles.

Therapeutic Areas and Scientific Approach

Focus on Neurological Disorders

Biogen's research in neurological disorders centers on neurodegenerative, demyelinating, and neuromuscular conditions, with a legacy rooted in pioneering (MS) therapies since the . The company employs a multifaceted scientific strategy emphasizing genetic drivers of disease, biomarker validation, and innovative modalities such as antisense oligonucleotides (ASOs), small-molecule inhibitors, and targeted protein degraders to modulate pathological processes like , , and neuronal loss. This approach prioritizes precision targeting, often through collaborations that enhance delivery across the blood-brain barrier, aiming to address unmet needs in diseases affecting over one billion people globally. In MS, Biogen's foundational contributions include Avonex (), approved by the FDA on May 23, 1996, as the first therapy for relapsing forms, followed by Tecfidera () in 2013, which reduces rates by activating the Nrf2 pathway to mitigate and immune dysregulation. The portfolio has expanded to five approved relapsing MS treatments, including Vumerity and Tysabri, focusing on immune modulation and B-cell depletion. Current efforts target remyelination and disability reversal, with BIIB091, a peripheral (BTK) inhibitor, in Phase 2 trials to inhibit B-cell and activation in MS progression. For , Biogen discontinued development and commercialization of (Aduhelm) on January 31, 2024, after its 2021 accelerated FDA approval amid over inconsistent Phase 3 data showing amyloid plaque reduction but ambiguous cognitive benefits, low uptake due to $56,000 annual pricing, and failure to meet confirmatory trial mandates. The company now co-promotes (Leqembi) with , FDA-approved on July 6, 2023, for early-stage disease via -beta clearance, alongside BIIB080, a tau-targeted ASO in Phase 2 for reducing neurofibrillary tangles. In (ALS), (Qalsody), an ASO for gene mutations, received accelerated FDA approval on April 25, 2023, and remains in Phase 3 for broader validation. Additional programs include BIIB122, an inhibitor in Phase 2 for ; zorevunersen, an ASO in Phase 3 for SCN1A-related ; and in Phase 3 for pediatric , reflecting a pipeline diversified across genetic and sporadic neurological etiologies as of July 31, 2025.

Expansion into Immunology and Rare Diseases

Biogen's expansion into immunology and rare diseases accelerated in the early 2020s as part of a strategic diversification effort to mitigate reliance on its multiple sclerosis portfolio amid patent expirations and competitive pressures. This shift involved targeted acquisitions and licensing deals to build a pipeline addressing unmet needs in autoimmune conditions and orphan indications, leveraging Biogen's expertise in biologics and small molecules. In rare diseases, a pivotal move was the $7.3 billion acquisition of , completed on September 27, 2023, which added Skyclarys (), the first FDA-approved therapy for , granted accelerated approval on August 15, 2023, for patients aged 16 and older. Skyclarys targets via Nrf2 pathway activation, addressing a neurodegenerative disorder affecting approximately 5,000 individuals in the U.S. with no prior approved treatments. Earlier, Biogen's 2016 collaboration with yielded Spinraza (), approved January 23, 2017, for (SMA), a rare genetic impacting about 1 in 10,000 live births; cumulative global sales exceeded $2 billion annually by 2022, though competition from gene therapies has since pressured market share. These efforts positioned rare diseases as a growth driver, with Reata's assets expanding Biogen's footprint in mitochondrial and neuromuscular disorders. Biogen's entry into immunology emphasized nephrology and systemic autoimmune diseases, marked by the July 2, 2024, completion of its $1.8 billion acquisition of Human Immunology Biosciences (HI-Bio), announced May 22, 2024, with $1.15 billion upfront. This deal secured felzartamab, an anti-CD38 in phase 3 trials for immunoglobulin A nephropathy (IgAN), primary membranous nephropathy, and —conditions often involving immune-mediated kidney damage affecting rare patient subsets. Felzartamab depletes CD38-expressing cells to reduce production, with interim data from the phase 2 IgAN trial showing reductions of up to 50% at 12 months. Complementing this, on October 24, 2025, Biogen licensed VQ-201, an oral C5aR1 antagonist from Vanqua Bio for $70 million upfront plus up to $990 million in milestones, targeting neutrophil-driven inflammation in autoimmune and inflammatory disorders. These immunology assets aim to address gaps in precision , with potential peak sales projections exceeding $2 billion if approved, though clinical risks remain given historical attrition rates in autoimmune .

Approved Products and Market Impact

Multiple Sclerosis Portfolio

Biogen's (MS) portfolio comprises disease-modifying therapies (DMTs) primarily targeting relapsing forms of MS, including , relapsing-remitting MS, and active secondary progressive MS. Key products include Avonex (), Tysabri (), Tecfidera (), Plegridy (peginterferon beta-1a), and Vumerity (diroximel fumarate), which have collectively treated over one-third of MS patients globally and positioned Biogen as a pioneer in MS therapeutics since the 1990s. These therapies reduce relapse rates, delay disability progression, and manage MRI lesion activity, though they vary in administration, efficacy profiles, and safety considerations such as (PML) risk with Tysabri. Avonex, an intramuscularly administered , was Biogen's first MS DMT, receiving FDA approval on May 17, 1996, for reducing and delaying progression in relapsing MS. Weekly dosing via prefilled syringe established it as a foundational injectable therapy, with long-term data supporting sustained efficacy in reducing annualized rates by about 30% in pivotal trials. Tysabri, a targeting alpha-4 to prevent immune cell migration into the , gained FDA approval on November 23, 2004, for relapsing MS after temporary market withdrawal in 2005 due to PML cases. Administered via monthly intravenous infusion, it demonstrates high efficacy in reducing relapses (up to 68% in monotherapy) and MRI activity but carries a black-box warning for PML, with risk stratified by anti-JCV antibody status, prior immunosuppressant use, and treatment duration exceeding two years. Tecfidera, an oral fumarate activating the Nrf2 pathway for anti-inflammatory and neuroprotective effects, was approved by the FDA on March 27, 2013, marking Biogen's entry into oral MS therapies. Twice-daily dosing showed relapse reduction of approximately 50% versus in phase 3 trials, contributing to peak annual sales exceeding $4 billion before generic erosion post-patent expiry. Plegridy, a pegylated form of for extended , received FDA approval on August 15, 2014, for every two weeks. It offers comparable efficacy to Avonex with reduced dosing frequency, achieving about 36% relapse reduction in trials, and serves as a next-generation injectable option. Vumerity, an oral diroximel fumarate converting to monomethyl fumarate (similar to Tecfidera), was approved by the FDA on October 30, 2019, to improve gastrointestinal tolerability while maintaining efficacy in relapsing MS. Twice-daily dosing supports relapse reduction aligned with Tecfidera data, positioning it as a differentiated oral alternative amid competition. Biogen also markets Fampyra (prolonged-release fampridine), approved in the in for symptomatic improvement in walking speed among MS patients with disability, though not a DMT; ex-U.S. rights were returned to Acorda Therapeutics in January 2024 amid declining sales. The portfolio's market impact includes historical revenue dominance, with MS products driving Biogen's growth through the 2010s, but recent declines due to biosimilars, generics (e.g., Tecfidera), and novel competitors have prompted diversification, with MS revenue expected to fall mid-single digits in 2025 from 2024 levels of approximately $4-5 billion. Despite this, ongoing from programs like MS PATHS underscores sustained benefits in patient outcomes across the portfolio.

Other Therapeutics Including SMA and Ophthalmology

Biogen's SPINRAZA (nusinersen) is an antisense administered intrathecally to increase survival motor neuron (SMN) protein production by modifying splicing of SMN2 pre-mRNA, addressing the genetic cause of (SMA). The U.S. (FDA) granted accelerated approval for SPINRAZA on December 23, 2016, as the first disease-modifying therapy for pediatric and adult patients with SMA, based on improvements in motor milestones and survival rates observed in clinical trials like ENDEAR and CHERISH. SPINRAZA received subsequent approvals in over 70 countries, including the on June 1, 2017, and has generated peak annual global sales exceeding $2 billion, though revenues have declined amid competition from gene therapies like Novartis' Zolgensma and Roche's Evrysdi. In treatment, SPINRAZA requires lifelong dosing every four months after loading doses, with a list price of approximately $750,000 for the first year and $375,000 annually thereafter, reflecting its foundational role despite access challenges and emerging alternatives. Biogen continues to pursue label expansions, including a higher-dose regimen under FDA review since January 2025, supported by data from the DEVOTE study showing enhanced efficacy in motor function for certain patients. Recent efforts include advancing investigational asset salanersen into registrational trials in June 2025, in collaboration with , to potentially offer an oral alternative. For , Biogen markets BYOOVIZ (-nuna), a to Roche's Lucentis (), developed in partnership with Bioepis and approved by the FDA on September 20, 2021, as the first for intravitreal use in the United States. BYOOVIZ is indicated for neovascular (wet) age-related , following retinal vein occlusion, and myopic , with and demonstrated through analytical, nonclinical, and clinical studies showing similarity to the reference product. Launched commercially in the U.S. in June 2022, BYOOVIZ received interchangeable designation from the FDA on October 3, 2023, enabling pharmacy-level substitution in some states and supporting cost reductions in retinal disease management. Biogen's ophthalmology portfolio remains limited to biosimilars like BYOOVIZ, with no proprietary small-molecule or biologic originators approved to date, though the company has invested in via the 2019 acquisition of Nightstar Therapeutics for $800 million to target inherited retinal dystrophies. These efforts underscore Biogen's strategy to expand beyond into high-unmet-need areas, with biosimilars providing market entry while proprietary programs face competitive pressures from established therapies.

Research and Development Pipeline

Late-Stage Clinical Programs

Biogen's late-stage clinical programs as of October 2025 encompass Phase 3 trials across , , and rare diseases, reflecting a strategic diversification beyond its core. These efforts include confirmatory studies for accelerated approvals and novel therapies targeting unmet needs in , , , kidney disorders, , and . Key assets involve , monoclonal antibodies, and small molecules, with several partnered developments such as with and dapirolizumab pegol with UCB. In neurology, tofersen (SOD1 antisense oligonucleotide) is in a Phase 3 confirmatory trial (ATLAS) for presymptomatic SOD1-ALS, evaluating delay in clinical manifestation onset following FDA accelerated approval of Qalsody in 2023 based on biomarker reductions in the VALOR study. Zorevunersen, an antisense therapy targeting SCN1A gene loss-of-function, advances to Phase 3 for , a severe developmental epileptic . Lecanemab (anti-amyloid beta ), co-developed with , features two Phase 3 trials: one for subcutaneous dosing in early and another for preclinical Alzheimer's to assess early intervention efficacy. Nusinersen, an approved SMN2 splice modulator for , undergoes Phase 3 evaluation for potential expanded indications. Immunology programs dominate with dapirolizumab pegol () in Phase 3 for systemic (SLE), showing promising topline results from the Phase 3 DAISY study and additional data presented at ACR Convergence 2025. Litifilimab () progresses in Phase 3 for SLE and cutaneous (CLE), building on Phase 2 proof-of-concept data demonstrating reductions in interferon gene signature and clinical activity; a long-term extension study assesses sustained safety and efficacy. Felzartamab () entered Phase 3 in March 2025 for late antibody-mediated rejection in kidney transplant recipients and in June 2025 for primary membranous nephropathy, with additional Phase 3 initiation for immunoglobulin A nephropathy (IgAN); interim data from earlier trials support reduction. Rare diseases include (Nrf2 activator), acquired via , in Phase 3 for pediatric following approval for adults as Skyclarys. These programs aim to verify clinical benefits, with risks including failure to meet endpoints as seen in prior trials, though assets show stronger momentum per company disclosures.

Early-Stage and Preclinical Efforts

Biogen has increasingly emphasized external collaborations and licensing deals to advance its preclinical pipeline, reflecting a strategic shift away from expansive in-house discovery efforts toward an "open innovation" model that leverages partnerships for early-stage assets. This approach, articulated by Biogen's leadership in early 2025, aims to prioritize high-potential external opportunities in , , and rare diseases while streamlining internal resources. In January 2025, the company reduced its internal research staff to align with a more focused preclinical footprint, redirecting investments toward acquisitions of preclinical candidates and collaborative IND-enabling studies. A key example is Biogen's October 24, 2025, licensing agreement with Vanqua Bio for an oral C5aR1 antagonist, a preclinical designed to inhibit neutrophil-driven implicated in autoimmune and inflammatory disorders. The deal includes $70 million upfront and up to $990 million in milestones plus royalties, positioning the asset for potential IND-enabling work in complement-mediated diseases. Earlier, on May 27, 2025, Biogen entered a strategic collaboration with City Therapeutics to develop RNAi-based therapies targeting a single genetic mediator of disorders, with options for an additional target; Biogen oversees IND-enabling studies, clinical development, and commercialization, supported by $46 million initial payments and up to $1 billion in milestones. In autoimmune diseases, Biogen advanced BIIB142, an IRAK4 degrader developed in with C4 Therapeutics, from preclinical stages to IND acceptance by the FDA on September 5, 2025, for evaluation in inflammatory conditions. Preclinical data highlighted its potential to degrade IRAK4, a involved in innate immune signaling. This external sourcing aligns with Biogen's broader preclinical emphasis on modalities like targeted degradation and to address unmet needs in and neurodegeneration, though specific internal discovery programs remain limited in public disclosure as of late 2025.

Financial Performance

Biogen's revenue peaked at $13.44 billion in 2020, driven by strong sales of (MS) therapies including Tecfidera and Avonex, but subsequently declined due to generic competition following patent expirations and erosion. From 2021 to 2023, annual contracted to $10.98 billion, $10.17 billion, and $9.83 billion, respectively, reflecting a cumulative drop of about 27% over the period amid reduced pricing power and losses in the MS segment, which historically accounted for over 70% of . In 2024, edged lower to $9.68 billion, a 1.6% decrease year-over-year, as legacy MS product declines partially offset gains from newer launches like Vumerity and Spinraza stability. Early 2025 data indicates a potential , with Q2 reaching $2.65 billion, up 7.3% year-over-year and exceeding analyst expectations, fueled by MS portfolio resilience (e.g., Vumerity growth) and initial ramp-up of Alzheimer's treatment Leqembi in partnership with . Trailing twelve-month as of June 30, 2025, stood at $10.00 billion, signaling 3.4% growth from the prior period and suggesting stabilization through diversified contributions from therapies like Skyclarys (acquired via in 2023) and Qalsody for . However, contract manufacturing is projected to remain minimal in late 2025 due to planned facility maintenance. Profitability has mirrored revenue volatility but shown resilience via cost controls and high gross margins. Net income fell from $4.00 billion in 2020 to $1.56 billion in 2021, influenced by one-time charges including Aduhelm-related impairments and litigation, before partial recovery to $3.05 billion in 2022 and a dip to $1.16 billion in 2023 amid ongoing R&D investments. In 2024, rebounded to $1.63 billion, yielding a of approximately 15.3%, bolstered by gross margins near 75% from efficient manufacturing of high-value biologics. Trailing twelve-month as of June 2025 was $1.53 billion, up 32% year-over-year, reflecting operational efficiencies despite elevated expenses in pipeline advancement.
YearRevenue ($B)Net Income ($M)Net Profit Margin (%)
202013.444,00129.8
202110.981,55614.2
202210.173,04730.0
20239.831,16111.8
20249.681,63216.9

Investments, Debt, and Shareholder Returns

Biogen allocates substantial resources to (R&D), spending $2.04 billion in 2024, down approximately 49% from $3.99 billion in 2020 amid efforts to optimize pipeline priorities and reduce costs following the termination of the Aduhelm program. The company anticipates combined non-GAAP R&D and selling, general, and administrative expenses of approximately $3.9 billion in 2025, reflecting continued investment in late-stage assets while trimming less promising efforts. Capital expenditures, focused on manufacturing capacity and operational infrastructure, totaled $154 million in 2024, representing about 1.6% of revenue, with quarterly outlays such as $27 million in Q2 2025 supporting . The firm's debt position remains moderate relative to its asset base, with long-term debt declining 33% to $4.55 billion by the end of 2024 from $6.79 billion in 2023, aided by debt repayments and generation. Total debt stood at $6.3 billion as of December 31, 2024, offset by $2.4 billion in and equivalents, yielding net of roughly $3.9 billion and a of 35.6%. By mid-2025, total debt had risen slightly to $6.59 billion, supported by operational flows exceeding $1 billion annually in recent years. Biogen has historically prioritized reinvestment over direct dividend payments, with no common stock dividends declared or paid in 2024 or prior recent years. Shareholder returns occur primarily through share repurchases under a 2020 authorization, with approximately $2.1 billion remaining available as of June 30, 2025; however, the company executed no buybacks in Q4 2024 or Q1 2025, reflecting a cautious approach amid pipeline uncertainties and revenue pressures from multiple sclerosis portfolio erosion. This limited repurchase activity contrasts with earlier phases of the program, contributing to a shares buyback ratio of -1.31% in recent periods, indicating net share issuance dynamics.

Business Development Activities

Acquisitions and Licensing Deals

Biogen has strategically pursued acquisitions and licensing deals to diversify beyond into rare neurological diseases, , and , often targeting late-stage assets to accelerate pipeline advancement. In July 2023, Biogen agreed to acquire for $172.50 per share in cash, representing an enterprise value of approximately $7.3 billion; the deal closed on September 26, 2023, integrating SKYCLARYS (), approved for , along with Reata's clinical and preclinical programs in neurology and rare diseases. In May 2024, Biogen announced the acquisition of Human Immunology Biosciences (HI-Bio) for an upfront payment of $1.15 billion plus up to $650 million in contingent milestones tied to development, regulatory, and sales achievements; the transaction completed on July 2, 2024, adding felzartamab, a CD38-directed in phase 3 for immune-mediated kidney diseases like and membranous nephropathy. Biogen's licensing efforts have focused on innovative modalities such as and small molecules. In August 2020, it entered a collaboration and license agreement with Therapeutics, providing $560 million upfront and a $465 million equity investment for co-development of inhibitors targeting , with options extending to other neurodegenerative programs using Denali's transport vehicle technology. In October 2025, Biogen licensed exclusive worldwide rights to Vanqua Bio's preclinical oral C5aR1 antagonist for inflammatory diseases, including potential applications in , for $70 million upfront, up to $990 million in milestones, and tiered royalties on net sales. Earlier licensing includes Biogen's collaboration with , initiated around 2010 for antisense in , culminating in global rights to (SPINRAZA) after exercising development options, supported by upfront payments exceeding $500 million cumulatively and milestone obligations that enabled commercialization following 2016 approval. These deals reflect Biogen's emphasis on external innovation to offset internal R&D challenges, though outcomes vary, as seen with the 2024 termination of certain Alzheimer's options due to clinical setbacks.

Divestitures, Spin-Offs, and Partnerships

Biogen spun off its global hemophilia business into an independent, publicly traded company named Bioverativ Inc. on February 1, 2017. The separation allowed Bioverativ to focus exclusively on hemophilia and rare bleeding disorders, retaining key products such as Eloctate (recombinant ) and Alprolix (recombinant ), which generated approximately $1.3 billion in 2016 revenue for Biogen. The move was intended to sharpen Biogen's focus on while providing Bioverativ with dedicated resources for blood disorder innovation; Bioverativ was later acquired by in a $11.6 billion deal announced in January 2018. Biogen has pursued limited divestitures, primarily non-core assets tied to larger transactions. In September 2025, during its $85 million acquisition of Alcyone Therapeutics' ThecaFlex DRx system, Biogen divested Alcyone's remaining therapeutic assets—including certain programs and the Falcon delivery device—to a newly formed independent entity, Neela Therapeutics Inc., backed by Biogen-provided convertible debt financing. This transaction enabled Biogen to isolate and retain only the spinal delivery technology aligned with its core priorities, while offloading extraneous pipeline elements. Earlier considerations, such as potential of its biosimilars business in 2024 for cost savings, were ultimately retained to support revenue amid pipeline investments. Biogen maintains an active portfolio of partnerships to bolster its in and related fields. In October 2024, it initiated a multi-target collaboration with Neomorph Inc. to discover and optimize small-molecule molecular glue degraders targeting proteins implicated in neurological diseases, with Biogen securing global development and rights. In May 2025, Biogen partnered with City Therapeutics on next-generation RNAi therapeutics, combining the latter's engineering platform with Biogen's expertise for undisclosed neurological indications, including an upfront payment recorded as acquired in-process R&D expense. Additional recent alliances include a February 2025 ex-North America licensing deal with Stoke Therapeutics for zorevunersen in , granting Biogen exclusive rights outside the U.S., Canada, and ; and a July 2024 biomarker development collaboration with and Fujirebio to validate plasma-based assays for using Biogen's clinical data. These agreements reflect Biogen's strategy of leveraging external technologies to address pipeline gaps in regulation, degradation, and diagnostics.

Aduhelm Development, Approval, and Termination

Biogen licensed the worldwide rights to , a human targeting aggregated forms of , from Neurimmune in 2007 under a collaborative development and license agreement. Development focused on its potential to reduce in early , with initial Phase 1b PRIME study results published in 2016 demonstrating dose-dependent clearance via PET imaging in patients with prodromal or mild Alzheimer's. Two identical Phase 3 trials, EMERGE (NCT02484547) and ENGAGE (NCT02477800), enrolled 3,285 patients with early Alzheimer's from August 2015 to around 2019, evaluating monthly intravenous doses up to 10 mg/kg against over 18 months, with primary endpoint of change in Clinical Dementia Rating-Sum of Boxes (CDR-SB) score. In October 2019, Biogen initially discontinued development citing futility analysis, but subsequent reanalysis of higher-exposure patients in EMERGE showed a 22% slower decline on CDR-SB (p=0.012), supported by secondary endpoints and 59-71% reduction; ENGAGE high-dose results were negative, attributed by Biogen to higher drop-out rates and . Biogen submitted a biologics license application (BLA) for aducanumab to the FDA in July 2020, accepted with in August and a PDUFA target of March 7, 2021, later extended to June. A November 2020 FDA advisory committee voted unanimously (10-0) that evidence did not confirm clinical benefit and 9-1 that risks, including () in up to 35% of high-dose patients, outweighed benefits. Despite this, on June 7, 2021, the FDA granted accelerated approval for Aduhelm (aducanumab-avwa) 100 mg/mL for intravenous use in patients with confirmed in early Alzheimer's ( or mild ), relying on reduction as a rather than direct clinical benefit confirmation, with required post-approval confirmatory trial ENVISION (NCT04437511) planned to start in 2022. Initial U.S. was set at $56,000 annually for the 10 mg/kg maintenance dose, later reduced to $28,200 in December 2021 amid limited uptake. Post-approval, Aduhelm generated minimal revenue—less than $3 million in the first half of 2022—due to payer restrictions, including a January 2022 CMS national coverage determination limiting use to patients in clinical trials, and ongoing efficacy debates. Biogen invested over $2 billion in development from 2007 through approval, with planned marketing exceeding $3 billion from 2020-2024, per internal documents cited in a 2022 congressional staff report criticizing pricing and FDA interactions. ENVISION initiation was delayed beyond 2022. On January 31, 2024, Biogen announced discontinuation of Aduhelm's development and commercialization, terminating the ENVISION study, returning global rights to Neurimmune, and phasing out U.S. access by November 1, 2024, after failing to secure a partner despite efforts; the decision incurred a $60 million one-time charge and aimed to reallocate resources to other Alzheimer's assets like lecanemab (Leqembi).

Marketing Practices and Kickback Allegations

In September 2022, Biogen agreed to pay $900 million to resolve allegations that it violated the False Claims Act and Anti-Kickback Statute by paying kickbacks to physicians to induce prescriptions of its drugs Avonex, Tysabri, and Tecfidera between January 2009 and March 2014. The whistleblower , initiated by former Biogen employee Matthew Bawduniak under the provisions of the False Claims Act, claimed the company used sham speaker programs, fake consulting arrangements, and lavish meals to remunerate high-prescribing doctors, targeting those responsible for approximately 60% of prescriptions for these drugs to maximize sales impact. Biogen denied any wrongdoing in the settlement, which included a record $250 million award to Bawduniak, but the payment resolved federal and state claims involving Medicare and reimbursements tainted by the alleged inducements. These practices were characterized as disguised marketing efforts to boost drug utilization, with internal Biogen strategies allegedly prioritizing remuneration to top prescribers over legitimate educational or advisory roles, leading to inflated federal healthcare expenditures. Speaker events, in particular, were purportedly nominal affairs with minimal attendance or substantive content, serving primarily as pretexts for honoraria payments ranging from thousands of dollars per event. The U.S. Department of Justice emphasized that such schemes undermine the integrity of healthcare provider decision-making and contribute to unnecessary prescribing, though Biogen maintained the programs complied with industry standards at the time. Separately, in December 2020, Biogen settled for $22 million over claims it funneled kickbacks through patient assistance foundations to cover copayments for Avonex and Tysabri, effectively subsidizing out-of-pocket costs to encourage prescriptions and violating the Anti-Kickback Statute by steering patients toward its products. The company again did not admit liability but entered the agreement to avoid protracted litigation, with the DOJ noting the foundations' role in masking direct financial incentives that distorted clinical choices. More recently, in August 2024, Biogen faced a class-action lawsuit alleging it paid kickbacks to major pharmacy benefit managers, including and , to preferentially place branded Tecfidera on formularies and disadvantage generic equivalents amid rising competition, potentially inflating costs for payers and patients. The suit claims these rebates and payments constituted improper inducements to manipulate formulary decisions, reflecting ongoing scrutiny of Biogen's promotional tactics in maintaining for high-revenue products. Biogen has contested the allegations, arguing they mischaracterize standard rebate negotiations.

Patent Infringements and Partner Disputes

In a dispute over antibody manufacturing , Genentech sued Biogen in March 2023, alleging breach of a 2004 license agreement covering the Cabilly family used in producing Tysabri, Biogen's and drug. The contention centered on whether Biogen owed royalties on post--expiration sales (after December 2018) of Tysabri manufactured using the patented methods prior to expiration, including stockpiled inventory sold in 2019 and later. On October 1, 2025, U.S. District Judge ruled in Genentech's favor, ordering Biogen to pay $88.3 million in past royalties plus interest, interpreting the license to require payments for such sales. Biogen has also faced challenges in enforcing its own patents, though fewer direct infringement claims against it. For instance, in Biogen International v. Mylan Pharmaceuticals (filed around 2017), Biogen alleged infringement of U.S. No. '514, covering methods of treating with dimethyl fumarate (the active ingredient in Tecfidera), after Mylan filed an . The U.S. Court of Appeals for the Federal Circuit upheld the district court's finding of validity and infringement in November 2021, but this positioned Biogen as the enforcer rather than the accused infringer. Partner disputes have included tortious interference claims related to drug development collaborations. In Ixchel Pharma, LLC v. Biogen, Inc., Ixchel alleged that Biogen interfered with its at-will contract with Forward Pharma for developing a dimethylfumarate-based by entering a 2017 settlement and licensing agreement with Forward that required terminating the Ixchel deal to resolve disputes over the compound. The California Supreme Court ruled in August 2020 that such interference with an at-will contract demands proof of an independently wrongful act, applying a rule-of-reason analysis to California's statute on trade restraints, ultimately affirming dismissal in Biogen's favor. In May 2025, Biogen filed suit against Neurimmune Therapeutics, seeking a that their collaboration agreement grants Neurimmune no ownership, license, or interest in a bispecific antibody developed by Biogen, and requesting a permanent to prevent Neurimmune from disclosing confidential information or pursuing related patents. The dispute arises from interpretations of rights under the partnership, with Biogen arguing exclusive control over the asset.

Operations and Infrastructure

Manufacturing Facilities and Capacity Expansions

Biogen maintains manufacturing operations primarily in the United States and , with the majority of its capacity located in North Carolina's (RTP). The RTP sites include two campuses: RTP Bio in Wake County, focused on biologics production for conditions such as , , and , featuring three factories (flexible, small-scale, and large-scale) that have undergone multiple expansions; and RTP Pharma in Durham County, which supplies clinical and commercial products for , , , and , encompassing four factories for antisense , parenteral filling, and oral solid . Across these campuses, Biogen operates seven manufacturing facilities, supported by a global installed capacity of 263,000 liters. In July 2025, Biogen announced a $2 billion investment over the next few years to modernize and expand its RTP facilities, including completion of an eighth factory operational by the second half of 2025, enhancements to antisense oligonucleotide capabilities, multi-platform fill-finish operations, and integration of advanced automation and . This initiative aims to bolster support for late-stage clinical pipelines and ensure , building on prior investments exceeding $10 billion in the region. In , Biogen's facility in Luterbach, operational since 2021 following groundbreaking in 2016 and a CHF 1.5 billion investment, features two production buildings (BMC1 and BMC2) each equipped with four 18,500-liter bioreactors for fed-batch and of biologics targeting neurodegenerative, hematological, and autoimmune diseases. The 36,510 square meter site, with its , effectively triples Biogen's overall biologics manufacturing capacity and received GMP multi-product licensing in May 2022.

Global Operations and Supply Chain

Biogen maintains a global operational footprint with its U.S. headquarters in , and international headquarters in , overseeing distribution and commercialization in regions including , , and beyond. The company supports this presence through subsidiaries such as Biogen Denmark A/S, Biogen Idec Ltd. in the , Biogen Luxembourg Holding SARL, and Biogen Norway AS, enabling localized and across multiple jurisdictions. Biogen's manufacturing operations emphasize biologic production, with facilities totaling 263,000 liters of installed capacity, positioning it among the largest in the sector. Its primary U.S. site in , —its largest manufacturing hub and the state's top biotech employer—has received approximately $10 billion in cumulative investments over 30 years, including a $2 billion expansion announced on July 21, 2025, to modernize capabilities, support pipeline advancement, and enhance supply resilience amid global disruptions. Internationally, Biogen is constructing a next-generation biologics facility in Luterbach near , , intended to become its largest production site upon completion, complementing domestic operations with European capacity. The company's strategy prioritizes geographical diversification, dual sourcing, and robust to mitigate vulnerabilities such as port congestion, strikes, and trade disruptions, ensuring uninterrupted delivery of therapies worldwide. Biogen employs end-to-end oversight, including ethical supplier screening and ESG integration, with annual reviews of over 200 Tier I suppliers to align with performance and risk goals, though it acknowledges ongoing challenges from global events impacting costs and reliability. Historical approaches have included rapid facility builds, technology upgrades for higher yields, and selective to balance innovation speed with capacity constraints.

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