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Biocon
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Biocon
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Biocon Limited is an Indian biopharmaceutical company based in Bengaluru, with U.S. headquarters in Bridgewater, New Jersey. The company was founded by Kiran Mazumdar-Shaw in 1978.[4] The company manufactures generic active pharmaceutical ingredients (APIs) that are sold in approximately 120 countries,[5] including the United States and Europe.[4] It also manufactures novel biologics as well as biosimilar insulins and antibodies, which are sold in India as branded formulations. Biocon's biosimilar products are also sold in both bulk and formulation forms in several emerging markets.[6]

Key Information

Biocon's formulations for the Indian market include metabolics, oncology, immunotherapy, and nephrology products. Some of Biocon's key brands in India include INSUGEN (rh-insulin), BASALOG (Glargine), BIOMAb EGFR (Nimotuzumab), BLISTO (Glimepiride + Metformin), CANMAb (Trastuzumab), Evertor (Everolimus), TACROGRAF (Tacrolimus), ALZUMAb (Itolizumab) and KRABEVA (Bevacizumab).[4]

Syngene International Limited (Syngene) is a publicly listed subsidiary of Biocon, operating in the contract research and development organization.[4]

History

[edit]

Biocon was founded in 1978 with US$10,000 as the initial capital by a Kiran Mazumdar who was born to Gujarati parents in Bangaluru.[7][8]

In 1979, Biocon became the first Indian company to manufacture and export enzymes to the US and Europe.[9]

In 1989, Unilever acquired Biocon Biochemicals Ltd. in Ireland and merged it with its subsidiary Quest International. Biocon received US funding for proprietary technologies.[10]

In 1994, Biocon established Syngene International as a custom research company.[10]

During 1998, Unilever agreed to sell its shareholding in Biocon to the Indian promoters. Biocon became an independent entity.[11]

In 2001, Biocon became the first Indian company to be approved by the USFDA for the manufacture of lovastatin; PlaFractor was granted a US 2001 and worldwide patent.[12]

In 2003, Biocon became the first company worldwide to develop human insulin on a pichia expression system.[13]

In 2006, BIOMAb EGFR, the first indigenously developed humanised monoclonal antibody for head-and-neck cancer, was launched, and APJ Abdul Kalam inaugurated India's largest biotech-hub, Biocon Park.[14]

In 2008, Biocon acquired a 70% stake in German pharmaceutical company AxiCorp GmbH.[15]

During 2009, a Syngene-Bristol Myers Squibb research facility was established in Bengaluru.[16]

Later in 2009, Mylan announced a strategic collaboration with Biocon to enter the global generic biologics market.[17]

In 2010, Biocon expanded to Malaysia, with a biopharmaceutical manufacturing and R&D facility established in Iskandar, Johor.[18]

In 2012, Abbott announced a collaboration with Syngene to open the first nutrition R&D center in India.[19]

During 2013, Biocon launched the biologic drug ALZUMAb to treat psoriasis.[20]

During 2014, Biocon launched the first biosimilar drug, CANMAb, to treat breast cancer.[21]

In 2015, Biocon launched a hepatitis-C drug in India under the brand name CIMIVIR-L.[22]

In 2016, Biocon became the first Indian company to launch a biosimilar insulin glargine pen in Japan.[23]

During 2016, Syngene set up an Amgen R&D center in Bangalore.[24]

In 2017, Biocon's Insugen became the first locally manufactured biosimilar product to be approved for sale by the Malaysian drug regulator.[25]

In 2017, USFDA approved Mylan-Biocon's biosimilar for the cancer drug Herceptin.[26]

During 2018, Biocon and Mylan received the European Commission's approval to market the biosimilar insulin glargine.[27]

During 2021, Biocon Biologics and Serum Institute of India formed a joint agreement to commercialise vaccines, biological drugs, and antibody therapies together.[28] Another aspect of the deal involved Bicocon selling 15% of its biologics subsidiary to the Serum Institute of India, in return for Biocon gaining access to 100 million annual doses of vaccines for a 15-year period.[28]

During 2022, Biocon Biologics bought the biosimilar assets of Viatris for $3.34 billion.[29]

Corporate governance

[edit]
Kiran Mazumdar-Shaw is an Indian entrepreneur. She founded Biocon in 1978.

Biocon's CMD Kiran Mazumdar-Shaw joined Biocon in 1978.[30][31][32] Her efforts in biotechnology have drawn global recognition both for the industry in India and for Biocon. She was called India's "biotech queen" by The Economist[33] and India's "mother of invention" by The New York Times.[34] She was named among Time magazine's 2010 100 most influential people in the world, not only due to her contribution to the biotech industry, but also because she gives back to the community.[35] Shaw has been featured on the Forbes list of "The World's 100 Most Powerful Women"[36] and in the Financial Times "Top 50 Women in Business" list.[37]

Shaw is the recipient of several awards including the Nikkei Asia Prize, 2009 for Regional Growth,[38] Express Pharmaceutical Leadership Summit Award 2009 for Dynamic Entrepreneur, The Economic Times 'Businesswoman of the Year', the 'Veuve Clicquot Initiative For Economic Development For Asia, Ernst & Young's Entrepreneur of the Year Award for Life Sciences & Healthcare, 'Technology Pioneer' recognition by World Economic Forum and the Indian Chamber of Commerce Lifetime Achievement Award. She has received two Indian national awards, the Padma Shri (1989) and Padma Bhushan (2005), for her pioneering efforts in industrial biotechnology.[30]

Christiane Hamacher was appointed as the CEO of Biocon Biologic India Limited, with her term starting in March 2019.[39]

On 3 December 2019, Siddharth Mittal took over from Arun Chandavarkar, who retired as CEO and joint managing director of Biocon.[40]

In 2021, Hamacher resigned from her position, following differences with Kiran Mazumdar-Shaw.[41]

Subsidiaries

[edit]

Biocon Biologics

[edit]
Inside Biocon Research Centre in Biocon Park, Bommasandra, Bangalore

Biocon Biologics is Biocon's biosimilar subsidiary. In 2021, Biocon and Viatris received approval to launch Semglee, an insulin glargine-yfgn injection, the first interchangble biosimilar for diabetes in the United States.[42] In 2021, Biocon sold 15% of Biocon Biologics to Serum Institute of India for a valuation of $4.9 billion, for which Biocon will receive access to 100 million doses of vaccines per annum for 15 years.[43] These vaccines will mainly be supplied from Serum Institute's upcoming vaccine facility in Pune, and Biocon will also have the commercialization rights of Serum Institute's vaccine portfolio, which includes the COVID-19 vaccine, for the international markets.[43] In May 2022, Viatris sold its biosimilars division to Biocon Biologics for a price of US$3.335 billion.[44]

Syngene International Ltd

[edit]

Established in 1993, Syngene International Limited is a contract research and development organization (CDMO). In the CDMO space, Syngene primarily focuses on research innovation and manufacturing services for their clients.[45] The company has four divisions: drug discovery services, dedicated research centres, development devices and manufacturing.[45] Syngene works with eight of the top 10 global pharma companies and, Syngene's clients include Amgen, Zoetis, GlaxoSmithKline and Bristol Myers Squibb.[46] Syngene has been expanding its operations. Since 2020, the company has opened an R&D centre in Hyderabad, is building an API manufacturing facility in Mangalore, which was scheduled to be commissioned in 2022, and has expanded their R&D facility in Bangalore.[47] Syngene also provides biologics CDMO services.[48] In July 2022, Syngene signed a 10-year agreement with Zoetis to manufacture the drug substance for Librela (bedinvetmab), a first-in-class monoclonal antibody used for treating osteoarthritis in dogs.[49] SynVent is Syngene's drug discovery and development platform for both small and large molecules.[50] In September 2022, Biocon divested 5.4% of its shares in Syngene International.[51]

Clinigene

[edit]

Clinigene International Limited is a subsidiary of Syngene offering international pharmaceutical majors Phase I-IV clinical trials and studies for novel/generic molecules.[30]

BBPL

[edit]

Biocon established Biocon Biopharmaceuticals Pvt. Ltd. (BBPL) in 2003 as a joint venture with the Cuban institute CIMAB to develop and market a range of MAbs and cancer vaccines.[30]

Biocon-AxiCorp

[edit]

In 2008, Biocon acquired a majority stake of 70% in AxiCorp GmbH, a German pharmaceutical marketing company.[52]

NeoBiocon

[edit]

Incorporated in January 2008, NeoBiocon FZ LLC is a research and marketing pharmaceutical company based in Abu Dhabi.[53]

Biofusion Therapeutics Limited

[edit]

Biofusion Therapeutics Limited was incorporated in March 2021. It is 100% owned by Biocon.[54]

Strategic partnerships

[edit]

Biocon and Amylin

[edit]

In 2009, Biocon and Amylin Pharmaceuticals of the United States entered into an agreement to develop, commercialise and manufacture a novel peptide therapeutic for the potential treatment of diabetes. Amylin provides expertise in peptide hormone development, particularly in the area of phybrid technology and metabolic disease therapeutics. Biocon will utilise its expertise in recombinant microbial expression and experience in preclinical and clinical development of diabetes products to manufacture the compound.[30]

Biocon and IATRICa

[edit]

In 2008, Biocon and IATRICa of the United States announced a strategic partnership to co-develop immunoconjugates for targeted immunotherapy of cancers and infectious diseases. The companies are co-developing candidate products based upon IATRICa's technology platform and Biocon's expertise in drug development, biologics manufacturing, and clinical research. The goal of this collaboration is to develop a therapeutic vaccine where the T cell-mediated immunity is enhanced and maintained against a tumor that otherwise evades immune responses. Methods of developing, characterising and scaling up of conjugated monoclonal antibody production are being currently studied.[30]

Biocon and Viatris

[edit]

In 2009, Biocon signed a collaboration agreement with Viatris to develop and commercialize generic biologics. Viatris and Biocon will share development, capital, and other costs to bring products to market. Viatris will have exclusive commercialisation rights in the USA, Canada, Japan, Australia, New Zealand, EU, and European Free Trade Association countries through a profit-sharing arrangement with Biocon.[30]

Biocon and Optimer

[edit]

Biocon and Optimer Pharmaceuticals, a biopharmaceutical company focused on the treatment of serious infections such as Clostridioides difficile infection (CDI), have entered into a long-term supply agreement for the commercial manufacturing of the active pharmaceutical ingredient, fidaxomicin.[4][30]

Biocon and Vaccinex

[edit]

Biocon is also developing fully human antibodies BVX 10 and BVX-20 with a US antibody technology partner, Vaccinex. The partnership was initiated in 2004. BVX 10 targets TNF (Tumor Necrosis Factor) which is expressed at high levels in patients with rheumatoid arthritis. Biocon's strategic partnership with Vaccinex allows access to their proprietary human antibody platform technology, thereby providing a strong IP protection to Biocon's antibody pipeline.[4][30]

Biocon and Abraxis

[edit]

In 2007, Biocon and Abraxis BioScience, Inc. entered into an agreement that helped Biocon out-license the rights to develop and market a biosimilar version of GCSF (Granulocyte Colony-Stimulating Factor) to North American and European markets.[30]

Biocon and Sandoz

[edit]

In January 2018, Sandoz (a Novartis division) announced a global partnership with Biocon to develop, manufacture, and commercialize multiple biosimilars in immunology and oncology for patients worldwide.[55]

Operations

[edit]

Biocon's manufacturing facilities are located at two sites in Bangalore.[30]

Biocon's R&D focuses on the entire drug development pathway – from process development to non-clinical and clinical research.[30]

Biocon offers 36 brands of products across the four therapeutic divisions of diabetology, nephrology, oncology, and cardiology.[4]

References

[edit]

Further reading

[edit]
Revisions and contributorsEdit on WikipediaRead on Wikipedia

Biocon

View on Grokipedia
from Grokipedia
Biocon Limited is an Indian multinational company founded on November 29, 1978, by as Biocon India Private Limited in a rented garage in Bengaluru, initially focusing on production from the of . Headquartered at the in Bengaluru, , it has evolved into a fully integrated enterprise specializing in the discovery, development, manufacturing, and commercialization of affordable biosimilars, generic formulations, active pharmaceutical ingredients (APIs), and research services, primarily targeting chronic conditions such as , cancer, and autoimmune diseases. With a workforce of 16,561 employees across 60 cities and representing 31 nationalities as of March 31, 2025, Biocon operates in over 120 countries, emphasizing through innovative, cost-effective therapies that have benefited more than 21 million patients globally. The company's business model integrates four core segments: biosimilars (contributing 58% of FY25 revenue), generics (19%), research services via its subsidiary Syngene International (23%), and APIs, supported by advanced manufacturing facilities and a robust R&D pipeline with over 1,200 patents granted or filed. Key milestones include being the first Indian firm to receive U.S. FDA approval for a biosimilar (Ogivri, trastuzumab) in 2017, which was commercialized in 2020, launching the world's first Pichia-based recombinant human insulin in 2004, and achieving USD 1 billion in annual revenue for its biosimilars business by 2024. In FY25, Biocon reported consolidated revenue of ₹16,470 crore (approximately USD 1.95 billion), a 5% year-over-year increase, driven by 78 product launches and 133 regulatory approvals, including biosimilars like Yesintek™ (ustekinumab) in the U.S. and generic liraglutide in the UK. Under the leadership of Executive Chairperson and founder , alongside Managing Director and CEO Siddharth Mittal, Biocon prioritizes sustainability and innovation, investing 7% of revenue (excluding Syngene) in R&D and earning recognition as one of the world's most sustainable companies with an ESG score of 69 in 2025. Its global footprint includes subsidiaries and facilities in , , , the , , and , with notable expansions such as the acquisition of a U.S. biologics facility in 2025. Committed to , Biocon's initiatives reached 353,342 individuals in FY25 through healthcare access programs, while maintaining high governance standards with over 90 cGMP approvals from more than 25 international regulators.

History

Founding and early development

Biocon India Private Limited was founded in 1978 by in Bengaluru, , with an initial capital of 10,000 rupees (approximately US$1,250 at 1978 exchange rates), as a between Mazumdar-Shaw and Biocon Biochemicals Limited, an Ireland-based company, in which she held a 70% stake. Operations began modestly from Mazumdar-Shaw's rented garage, employing just three people initially, amid significant challenges including banks denying her loans due to gender bias and skepticism about a young woman's ability to lead a in the male-dominated industrial sector. The company's early focus was on the production of , starting with —a plant-derived enzyme from —and isinglass, a marine hydrocolloid used in , along with enzymes for applications in textiles and . In 1979, Biocon achieved a milestone as the first Indian company to export enzymes internationally, shipping products to the and , which helped establish its foothold in global markets despite limited resources and infrastructure. During the 1980s and 1990s, Biocon transitioned from manufacturing toward biopharmaceuticals, leveraging its expertise in processes to expand into more complex biotechnological applications. The company established dedicated facilities and scaled up in-house R&D programs, particularly in proprietary solid-state —known as "Koji" —to develop enzymes and bioactive molecules, marking the shift from industrial products to innovative biotech solutions. This period laid the groundwork for Biocon's evolution into a leader in biosimilars, building on its foundational strengths in and production.

Key milestones and expansions

In 2001, Biocon achieved a significant breakthrough by becoming the first company globally to receive U.S. Food and Drug Administration (USFDA) approval for the production of Lovastatin active pharmaceutical ingredient (API) using solid-state fermentation technology, marking the Indian biotech firm's entry into regulated markets for fermentation-based generics. This momentum continued in 2003 when Biocon developed and launched INSUGEN, the world's first Pichia-based recombinant human insulin, establishing it as India's pioneering biosimilar insulin product and enabling affordable diabetes treatment for millions. The company's public listing in 2004 through a highly successful (IPO) on Indian stock exchanges valued Biocon at over USD 1.1 billion on the first day, providing capital for further expansion into branded formulations and generics while solidifying its position as a leading innovator. In 2006, Biocon introduced BIOMAb EGFR (Nimotuzumab), India's first indigenously developed for , which received regulatory approval and has since treated thousands of patients, highlighting the firm's advancements in novel biologics. Biocon's strategic expansions in the late included the establishment of its first overseas manufacturing facility in Bio-XCell, Johor, , dedicated to insulin production to serve Southeast Asian and global markets, alongside the acquisition of a 70% stake in AxiCorp GmbH in for EUR 30 million to facilitate entry into European generics and biosimilars distribution. These moves supported Biocon's broader pivot into generics through fermentation-derived APIs and biosimilars via key partnerships, such as the 2009 collaboration with for co-developing and commercializing and insulin biosimilars worldwide, which accelerated market access and technological scaling into the early 2010s. Further global outreach involved setting up operations through subsidiaries like , enhancing and European efforts for biologics up to the early .

Recent developments

In November 2022, Biocon Biologics completed the acquisition of substantially all of ' global biosimilars business for up to $3.335 billion in cash and stock, integrating eight commercialized products and creating a fully integrated biosimilars enterprise; this transaction also involved rebranding and consolidating operations under Biocon Biologics. As part of its biosimilars expansion, Biocon continued commercialization of Fulphila (pegfilgrastim-jmdb), a to Neulasta originally co-developed with (now ) and integrated into Biocon's portfolio following the 2022 acquisition, with ongoing U.S. market presence to support cancer patients reducing infection risk. In September 2025, the U.S. FDA approved Biocon Biologics' , Bosaya (denosumab-kyqq) referencing Xgeva and Aukelso (denosumab-kyqq) referencing Prolia, for treating , bone loss, and cancer-related bone issues, marking entry into this high-value market projected at $4.9 billion in 2024. Biocon reported consolidated total revenue of ₹16,470 for FY 2024-25 (ended March 31, 2025), reflecting 5% year-over-year growth driven by biosimilars and generics, alongside a net profit of ₹1,013 , supported by operational efficiencies and portfolio expansion. In September 2025, Biocon inaugurated its first U.S. manufacturing facility in , investing over $30 million to produce oral solid with an annual capacity of 2 billion tablets, enhancing and access to affordable therapies in . In November 2025, Biocon announced Q2 FY26 operating revenue of ₹4,296 , a 20% increase year-over-year, driven by strong performance in and research services. The company is exploring a potential merger with its Biocon Biologics, valuing the unit at approximately USD 4.5 billion, with options including share swaps under review. Additionally, a proposal to streamline clinical testing requirements for could reduce Biocon's development costs by up to 50%. Biocon Biologics also received FDA approval for Kirsty™, the first interchangeable to Novolog (), further expanding its portfolio in the market. During the , Biocon contributed to global response efforts by repurposing its biologic itolizumab for treatment, securing in in 2020, and advancing R&D collaborations for antigens through its Syngene, while launching internal campaigns to promote and ensure uninterrupted supply of . This work bolstered Biocon Biologics' role in emergency preparedness without detailing operations further.

Business overview

Core business areas

Biocon operates through three primary business segments: biologics, generics, and services. The biologics segment, managed primarily through its Biocon Biologics, focuses on developing and commercializing biosimilars and novel biologics targeting complex therapies for chronic conditions. This includes monoclonal antibodies, insulins, and other advanced molecules aimed at , , and related fields. The generics segment involves the production of small-molecule active pharmaceutical ingredients (APIs) and finished dosage formulations, emphasizing affordable versions of . Meanwhile, the services segment, delivered via Syngene International, provides contract , development, and manufacturing organization (CRDMO) solutions to global pharmaceutical and biotech clients across the drug discovery continuum. The company maintains a strong market presence in key therapeutic areas such as diabetology, oncology, nephrology, and cardiology, where it addresses unmet needs in chronic disease management through biosimilars and generics. Biocon's products and services reach patients in over 120 countries, spanning advanced markets like the , , and , as well as emerging regions in , , , and the . This global footprint is supported by strategic partnerships, regulatory approvals, and direct commercialization efforts, enabling broad access to its offerings. Biocon adopts an innovation-led approach centered on enhancing affordable access to complex molecules, investing 7-9% of its revenue in research and development to advance biosimilars, generics pipelines, and novel therapies. This strategy leverages technologies like AI/ML and synthetic biology to reduce costs and improve outcomes in high-burden areas such as diabetes and cancer. As of fiscal year 2025, the company employs approximately 16,561 people worldwide, fostering a workforce skilled in biotechnology and pharmaceuticals. Its U.S. headquarters in Bridgewater, New Jersey, coordinates North American operations, including commercialization and regulatory activities for its global segments.

Products and services portfolio

Biocon's products and services portfolio encompasses a range of offerings, including branded formulations, , generics, and research services, primarily targeting , , and therapeutic areas. The company's branded formulations include INSUGEN, a recombinant human insulin available in regular, NPH, and biphasic forms for , marketed in markets such as , , and several African and Latin American countries. Another key branded product is CANMAb, a for HER2-positive treatment, approved and commercialized in . Additionally, Itolizumab, a novel biologic , targets by inhibiting CD6-mediated T-cell activation and has received approval in for moderate to severe cases; in 2025, it showed positive Phase 2 data for treatment, and Biocon regained full development and commercialization rights following termination of its with Equillium. In the biosimilars segment, Biocon offers a diversified lineup with global approvals, focusing on affordability in chronic . Notable products include Ogivri, a biosimilar approved by the U.S. FDA and EMA for HER2-positive breast and gastric cancers, also available in and under the same brand. Fulphila, a biosimilar, is approved in the U.S., , , and to reduce risk in patients. For , Basalog () and its variants like Semglee have secured approvals in the U.S., , , and several emerging markets including , , and . Other biosimilars in the portfolio encompass variants such as Krabeva, approved in for various cancers, and additional brands like Hertraz in . Recent launches include Yesintek™ () approved in the U.S. in 2025 for , , and , as well as Bosaya™ and Aukelso ( biosimilars) which entered the U.S. market in October 2025. Biocon's generics portfolio emphasizes fermentation-based active pharmaceutical ingredients (APIs) and formulations, particularly in and . Key offerings include simvastatin, a API and formulation for management, commercialized in the U.S. and supplied globally. , another fermentation-derived , supports cardiovascular therapies and is part of Biocon's legacy in biofermentation technologies. These generics extend to immunosuppressants, anti-diabetics, and APIs, ensuring cost-effective access in regulated markets; notable recent approvals include generic in the UK in FY25. Complementing its product lines, Biocon provides integrated research services through its subsidiary Syngene International, specializing in , development, and clinical trials. These services span target identification to candidate delivery in discovery, pre-clinical to Phase III trials in development, and cGMP-compliant manufacturing support, serving major global pharmaceutical clients across small and large molecules. The platform enables end-to-end solutions for biosimilars and novel biologics, with capabilities in , , and metabolic disorders.

Operations

Manufacturing facilities

Biocon's primary manufacturing hub is situated in Bengaluru, , featuring integrated facilities for the production of active pharmaceutical ingredients (APIs), biologics, and formulations. The Biocon Park, spanning 90 acres, supports API manufacturing via , synthetic chemistry, peptides, and high-potent APIs, alongside oral solid . Adjacent facilities in Bengaluru, including the 350,000-square-foot B3 monoclonal antibodies plant, enable the production of multiple biosimilars, with capacities supporting over 10 such products across , , and other therapeutic areas. Internationally, Biocon operates a 562,000-square-foot facility in , , specializing in sterile injectables such as insulins, marking it as Asia's largest integrated insulins manufacturing site. In September 2025, the company inaugurated its first U.S. facility in , through subsidiary Biocon Generics Inc., dedicated to commercial production of oral solid tablets with an annual capacity of 2 billion units. The facility underwent a successful U.S. FDA GMP inspection in October 2025. Additional sites in Hyderabad and , , focus on synthetic chemistry APIs, peptides, and high-potent intermediates. These facilities maintain rigorous regulatory compliance, holding approvals from the U.S. FDA, EMA, CDSCO (), PMDA (), TGA (), and over 25 other agencies, ensuring adherence to cGMP standards. Biocon integrates practices, such as zero-liquid discharge systems, across all units to enable 78% wastewater recycling in FY25 and minimize environmental impact. Collectively, Biocon's nine manufacturing sites across Biocon Limited and Biocon Biologics—primarily in , with additional facilities in and the U.S.—encompass over 1 million square feet of production space, facilitating scalable operations integrated with R&D for optimization.

Research and development

Biocon maintains a dedicated (R&D) center in Bengaluru, , spanning multiple facilities including the Biocon Campus and Biocon Park, where over 900 scientists across Biocon Limited and Biocon Biologics conduct research. This infrastructure supports end-to-end , from discovery to clinical stages, with a focus on biosimilars and novel biologics. The company's annual R&D investment for FY 2025 reached ₹858.5 (gross), representing approximately 7% of revenues excluding its Syngene, underscoring a commitment to sustained in . This expenditure, equivalent to about 9% when including broader group activities, funds advancements in key technologies such as the Pichia pastoris expression system for recombinant human insulin production, monoclonal antibody engineering for complex biologics, and integrated development platforms using microbial and mammalian cell lines. Biocon's R&D pipeline features a robust portfolio of over 20 biosimilars, with at least 12 assets under development in clinical or late preclinical stages targeting autoimmune diseases (e.g., biosimilars for inflammatory conditions), (e.g., biosimilars like Jobevne™), and (e.g., biosimilars). Notable novel molecules include itolizumab, a first-in-class anti-CD6 approved in for that completed Phase 3 trials for acute in 2025 (missing primary endpoint but meeting secondary endpoints) and Phase 2 trials for (positive results), though further development for the latter was paused following termination of a key collaboration in September 2025. To drive affordable innovation, Biocon emphasizes collaborations with academic institutions, including the Institute of Bioinformatics and Applied Biotechnology (IBAB) in Bengaluru for and strain development, for advanced bioprocessing, and international partners like the and for biosciences education and research. These partnerships enhance capabilities in emerging markets by prioritizing cost-effective solutions for chronic diseases, enabling broader access to high-quality biologics. Commercialization of assets often occurs through strategic alliances, as detailed in Biocon's partnerships section.

Corporate governance

Leadership and board

Biocon's leadership is spearheaded by its founder, , who established the company in 1978 and has served as Executive Chairperson since its inception, guiding its evolution from an enzyme producer to a global leader. Siddharth Mittal assumed the role of CEO and Managing Director effective December 1, 2019, bringing over two decades of experience in finance, mergers, and biopharma operations to oversee strategic growth and operational efficiency. The Board of Directors comprises nine members, including five independent directors to ensure objective oversight, alongside two executive directors and two non-executive non-independent directors. With two women members on the board, including the Executive Chairperson, the composition underscores Biocon's focus on gender diversity in . The board operates through specialized committees to enhance accountability and decision-making. The , chaired by Bobby Kanubhai Parikh and comprising Nicholas Robert Haggar and Atul Dhawan, supervises financial reporting, internal audits, and compliance to maintain transparency. The Nomination and Remuneration Committee, led by Lead Naina Lal Kidwai with members Rekha Mehrotra Menon and Ravi Mazumdar, handles director nominations, board diversity assessments, for senior management, and performance-linked remuneration structures. The Corporate Social Responsibility (CSR) Committee, also chaired by Naina Lal Kidwai and including Rekha Mehrotra Menon, Ravi Mazumdar, Siddharth Mittal, Eric Mazumdar, and Nicholas Robert Haggar, develops and monitors CSR policies aligned with sustainability and environmental, social, and governance (ESG) objectives. Biocon's governance framework prioritizes ethical standards via its comprehensive and Policy for Anti-Bribery and Anti-Corruption, which apply to all directors, employees, and stakeholders to foster integrity and prevent misconduct. Diversity is embedded in policies such as the Board Diversity Policy and Diversity, Equity, Inclusion & Belonging Policy, promoting women in leadership through initiatives like BioWin, a forum for inclusivity, with a target of across the organization by 2030. The company adheres to SEBI guidelines for sustainability reporting, integrating ESG disclosures into its annual business responsibility and sustainability reports to ensure transparency on environmental and social impacts. Key governance initiatives include robust managed by the Nomination Committee to identify and develop future leaders, and frameworks that link pay to key performance indicators such as revenue growth and milestones. This leadership structure has influenced pivotal strategic decisions, including global expansions in biosimilars.

Ownership and financial performance

Biocon Limited has been publicly listed on the (BSE) and the National Stock Exchange (NSE) since May 2004. The company's ownership structure features a promoter holding of approximately 54.45%, primarily controlled by and her family through direct stakes and promoter group entities such as Glentec International. This stable promoter involvement underscores long-term strategic control amid public shareholding by institutional investors (around 20%) and retail holders (about 25%). In 2024-25 (ended March 31, 2025), Biocon achieved consolidated revenue of ₹16,470 , reflecting a 5% year-over-year increase driven largely by growth in its biosimilars segment. Net profit stood at ₹1,013 , a slight decline year-over-year, supported by operational efficiencies and one-time gains, while total assets reached ₹58,797 . The company pursued aggressive debt reduction, redeeming ₹1,070 in non-convertible debentures in October 2025 and leveraging a ₹4,500 equity raise via qualified institutional placement in June 2025, bringing net debt close to zero and enhancing financial flexibility. As of November 2025, Biocon's was approximately ₹55,000 , reflecting steady performance with shares trading around ₹420 on NSE. The company's emphasizes a balanced approach, recommending an annual final post-year-end results—such as the ₹0.50 per share payout for FY 2024-25—while considering interim dividends based on profitability, cash flows, and growth needs; are managed through regular disclosures and engagement via the company's website. Biocon maintains strong ESG credentials, earning an ESG Score of 71 in 2025 and inclusion in the Sustainability Yearbook for the third consecutive year, ranking in the top 5% of peers. This performance has facilitated access to sustainability-linked financing, including a $1.2 billion loan tied to environmental and social targets as part of its 2022 biosimilars acquisition and subsequent refinancings.

Subsidiaries and affiliates

Biocon Biologics

Biocon Biologics was established as a of Biocon Limited in 2019 to consolidate and advance the group's biosimilars operations, focusing on the development and commercialization of complex biologics such as monoclonal antibodies and recombinant proteins for treating cancer, autoimmune diseases, and . This formation marked a strategic shift toward dedicated for biosimilars, enabling specialized scaling in high-value therapeutic areas. Following the acquisition of Inc.'s global biosimilars business in November 2022 for up to USD 3.335 billion in cash and stock, Biocon Biologics was positioned as a separately managed entity with enhanced independence, integrating acquired assets to form a fully integrated global biosimilars leader. The company's portfolio comprises over 10 approved biosimilars, including trastuzumab (branded as Ogivri, first U.S. FDA-approved in 2017) and adalimumab (branded as Hulio, approved in the EU in 2018 and U.S. in 2020), with regulatory approvals in the U.S., EU, and more than 40 other markets worldwide. Recent 2025 approvals include denosumab biosimilars Bosaya™ and Aukelso™ by the U.S. FDA in September, interchangeable rapid-acting insulin aspart Kirsty™ by the U.S. FDA, and ustekinumab biosimilar Yesintek™ by Health Canada in October. These products target oncology, immunology, and ophthalmology, providing affordable alternatives to originator biologics and addressing unmet needs in non-communicable diseases. Additionally, Biocon Biologics maintains a robust development pipeline of over 15 molecules, spanning diabetology, oncology, immunology, and ophthalmology, with several assets advancing toward regulatory submissions and launches. Operations are centered on dedicated manufacturing facilities in Bengaluru, , which support large-scale production of biologics under stringent global standards, including U.S. FDA and EMA compliance. These sites emphasize sustainable practices, such as and green energy usage, to ensure efficient global supply chains. Biocon Biologics drives commercialization through partnerships and direct presence in over 120 countries, contributing approximately 58% to the Biocon Group's overall revenue in FY 2024-25, with its standalone revenue reaching ₹2,954 . While operating with strategic independence, it leverages Biocon Limited's parent R&D expertise for pipeline innovation and process optimization.

Syngene International

Syngene International Limited, incorporated in 1993 as a custom research subsidiary of Biocon Limited, operates as an innovation-led contract research, development, and manufacturing organization (CRDMO). It went public in 2015 through an on the and National Stock Exchange, raising funds to expand its research and manufacturing capabilities. The company delivers end-to-end services spanning , , clinical trials, and commercial manufacturing, enabling clients to accelerate therapeutic innovation across small and large molecules. Key offerings encompass discovery and synthesis, where Syngene supports target identification, , and development up to commercial scale using cGMP-compliant processes. In biologics development, it provides integrated solutions for monoclonal antibodies, recombinant proteins, and other large molecules, including process optimization and scale-up in single-use systems. is facilitated through Clinigene, its fully integrated unit, which handles Phase I-IV trials, studies, and pharmacokinetic assessments in compliance with ICH-GCP standards for regulated markets. These services are unified under the SynVent platform, allowing seamless progression from early discovery to late-stage development. This integrated approach establishes Syngene's niche competitive moats, including its one-stop CRAMS platform and strong technical execution, which enhance efficiency and productivity in delivering comprehensive solutions to clients. Syngene serves more than 400 active clients worldwide, including major pharmaceutical and firms such as , , and GSK, with engagements spanning biopharma, nutrition, animal health, and specialty chemicals. In 2024-25, the company reported consolidated revenue of ₹3,714 , reflecting a year-over-year growth of 3.8% driven by steady demand in discovery services and biologics manufacturing, despite sector headwinds. This performance underscores its role as a resilient partner for global R&D . The company's operations are supported by multiple facilities in Bengaluru and Hyderabad, , encompassing over 2.5 million square feet of R&D and space equipped for , studies, and large-scale production. These sites maintain rigorous quality standards, including ISO 9001 certification for and AAALAC accreditation for animal care, alongside approvals from regulators like the US FDA and EMA. Syngene also integrates with Biocon's broader product to support internal initiatives.

Other key subsidiaries

Biocon Biopharmaceuticals Private Ltd. (BBPL) is a wholly owned of Biocon Limited, established as a with Cuba's CIMAB S.A. to focus on the manufacturing and commercialization of products, including monoclonal antibodies and other biologics. Following Biocon's acquisition of CIMAB's stake in 2010, BBPL has supported clinical development and regulatory affairs for select biotechnology-based therapeutics, contributing to the group's portfolio. NeoBiocon FZ-LLC, a 49% associate of Biocon in the UAE, operates as a with Neopharma to manufacture and market affordable generic and novel pharmaceuticals in the region. Established to leverage local production capabilities, it emphasizes and cardiovascular treatments, such as partnerships for distributing vildagliptin-based therapies. Biofusion Therapeutics Limited, incorporated in 2021 as a wholly owned , specializes in the of novel fusion proteins and targeted therapies, particularly in immuno-oncology and autoimmune diseases. In FY25, a scheme of amalgamation with Biocon Pharma Limited was approved, though its completion status as of 2025 remains pending. The entity focuses on innovative molecular designs to address unmet needs in precision medicine, building on Biocon's expertise in biologics . These subsidiaries collectively bolster Biocon's presence in niche segments, including active pharmaceutical ingredients (APIs) production and international distribution networks, enabling expanded access to specialized therapies in emerging markets.

Strategic partnerships

Biosimilar and drug development alliances

Biocon established a long-term strategic partnership with Mylan in June 2009 to co-develop and commercialize a portfolio of biosimilars globally, with a focus on insulin analogs and monoclonal antibodies such as trastuzumab (branded as Ogivri) and insulin glargine (branded as Semglee). Under the agreement, the companies shared development costs, manufacturing responsibilities, and commercialization rights, enabling joint regulatory submissions to agencies including the U.S. FDA and the European Medicines Agency (EMA). This collaboration facilitated approvals for multiple products, including the FDA's interchangeable designation for Semglee in 2021 and launches in key markets like the U.S. and Europe, contributing to expanded patient access for oncology and diabetes treatments. The partnership evolved following Mylan's merger into Viatris, culminating in Biocon Biologics' acquisition of Viatris' global biosimilars business in November 2022 for approximately $3.3 billion, which integrated the portfolio and retained shared economic interests while enhancing Biocon's direct control over commercialization. In January 2018, Biocon entered an exclusive global collaboration with , a division of , to develop, manufacture, and commercialize next-generation biosimilars targeting and indications. The agreement outlined shared responsibilities for end-to-end development and regulatory approvals, with cost and profit-sharing mechanisms; led commercialization in and the , while Biocon handled the rest of the world, including and CIS countries. In February 2024, the partnership extended to commercialization, with distributing Biocon's trastuzumab (Ogivri) and bevacizumab (Abevmy) biosimilars in . This partnership built on Biocon's expertise in biologics and complemented 's established market presence, aiming to accelerate access to affordable treatments for immune-mediated diseases, though specific product launches under this deal remain focused on pipeline advancements rather than named adalimumab variants like Hyrimoz, which is 's independently developed . Biocon Biologics forged a with () in September 2021 to expand into and biologics, particularly for communicable diseases, with an emphasis on like Covishield and Covovax, alongside biosimilars for emerging markets. The deal granted Biocon access to at least 100 million doses annually from SII's facilities for 15 years, along with commercialization rights to SII's portfolio in global markets, including and other developing regions, while SII acquired a significant equity stake in Biocon Biologics valued at around $4.9 billion post-money. The partnership was restructured in April 2023, preserving annual access to 100 million doses and distribution rights while adjusting equity arrangements. This tie-up leveraged Biocon's sterile fill-finish capabilities and biosimilars infrastructure to support production and distribution, targeting equitable access in low- and middle-income countries amid the and beyond. In March 2024, Biocon Biologics entered a 10-year supply agreement with Eris Lifesciences for the distribution of biosimilars in , effective April 1, 2024, to enhance market access for , , and treatments. In 2025, Biocon Biologics expanded its partnership with Civica, Inc., to include supply of drug substance (announced March 2025) and the launch of private-label (October 2025) in the U.S., aiming to broaden affordable treatment options. These alliances have driven key outcomes, including multiple joint regulatory filings and approvals with the FDA and EMA—such as and biosimilars under the partnership—and revenue-sharing models that have generated biosimilars income exceeding $500 million annually by 2023 for Biocon. The collaborations have secured for products in over 100 countries, enhancing affordability and penetration in both developed and emerging economies through coordinated launches and distribution networks.

Research and commercialization collaborations

Biocon has pursued strategic research and commercialization collaborations to advance novel therapeutics in areas such as , infectious diseases, , and autoimmune disorders, leveraging partnerships that combine its expertise with partners' discovery platforms. In the 2000s, Biocon entered an exclusive global agreement with to co-develop and commercialize a novel hybrid aimed at treating by reducing glucose levels and promoting . Under the terms, development costs were shared, with Amylin retaining intellectual property rights to the and phybrid technology while Biocon secured IP and led clinical development; commercialization rights were divided regionally, with Amylin handling , Biocon covering most of , and joint efforts elsewhere. This integrated with Biocon's internal R&D to accelerate -based innovations for and . Similarly, Biocon collaborated with Optimer Pharmaceuticals on the development of , a for treating difficile-associated infections, culminating in a long-term and agreement in 2010. Biocon utilized its capabilities to produce the active pharmaceutical ingredient, ensuring a stable for this first-in-class anti-infective while sharing development insights to optimize therapeutic . In and , Biocon partnered with Vaccinex to discover and co-develop humanized monoclonal targeting , , and autoimmune diseases, including potential applications in therapies through Vaccinex's proprietary platforms. The agreement combined Vaccinex's antibody discovery technology with Biocon's clinical development and strengths, supported by Biocon's equity investment of approximately Rs. 218,151 in to advance bio-better antibody candidates. Additionally, Biocon in-licensed Abraxane from Abraxis BioScience, a albumin-bound formulation for , securing marketing rights in and emerging markets to expand access to this targeted . For immuno-oncology, Biocon invested in IATRICa, a biotech startup, acquiring a 30% stake worth Rs. 138,470 to co-develop targeted immuno-conjugates that enhance T-cell responses against tumors, including R&D fees of Rs. 30,058 and initiation of two novel molecule programs by 2010. These early collaborations provided Biocon with access to cutting-edge intellectual property, shared funding for high-risk R&D, and co-marketing opportunities in the US and EU markets, enabling technology transfer and global commercialization of innovative therapies. More recently, in 2024, Biocon Foundation partnered with the Indian Institute of Science (IISc) to establish an AI-Center of Excellence for oral cancer projects, focusing on AI-driven discovery and screening tools to identify novel therapeutic targets, including antibody-based interventions for early detection and treatment. This multicentric initiative integrates AI algorithms with Biocon's biologics expertise to accelerate development of precision oncology solutions, marking a shift toward technology-enabled R&D collaborations.

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