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Biocon

From Wikipedia, the free encyclopedia

Biocon Limited
TypePublic
BSE: 532523
NSE: BIOCON
ISININE376G01013
Industry
Founded1978 (48 years ago) (1978)
FounderKiran Mazumdar-Shaw
Headquarters
Bengaluru, Karnataka
,
India
Key people
  • Kiran Mazumdar-Shaw (executive chairperson)
  • Peter Bains (Group CEO)
  • Siddharth Mittal (CEO & Managing Director)
  • Shreehas P Tambe (CEO & Managing Director, Biocon Biologics Limited)
Products
  • Biologics
  • Small molecules
  • Branded formulations
  • Research services
RevenueIncrease ₹16,470 crore (US$1.7 billion) (2025)
Increase ₹4,374 crore (US$450 million) (2025)
Decrease ₹1,013 crore (US$110 million) (2025)
Total assetsIncrease ₹58,797 crore (US$6.1 billion) (2025)
Total equityIncrease ₹27,712 crore (US$2.9 billion) (2025)
Number of employees
16,545 (March 2023)[1]
Subsidiaries
  • Biocon Biologics
  • Syngene International
Websitewww.biocon.com
Footnotes
Financials as of 31 March 2025.[2][3]

Biocon Limited is an Indian biopharmaceutical company based in Bengaluru, with U.S. headquarters in Bridgewater, New Jersey. Founded by Kiran Mazumdar-Shaw in 1978 as a partner to the Irish brewing enzyme manufacturer Biocon Biochemicals Ltd., the company manufactures generic active pharmaceutical ingredients (APIs) that are sold in approximately 120 countries, including the United States and Europe.[4][5] It also manufactures novel biologics, and branded drugs such as biosimilar insulins and antibodies for the Indian domestic market. Biocon's biosimilar products are also sold in both bulk and formulation forms in several emerging markets.[6]

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 formed in 1978 as Biocon India Private Limited, an India-based partner to the existing Irish multinational brewing enzyme producer Biocon Biochemicals Ltd., with $10,000 USD as startup capital from Mazumdar-Shaw.[7][8] The subsidiary initially produced enzymes for the brewing market such as the papaya enzyme papain and the fish collagen extract Iisinglass, a clarifying agent used for some beers and wines.[9] In 1979, Biocon became the first Indian company to manufacture and export enzymes to the US and Europe, and spent the 1980s producing an increasing share of pharmaceuticals for the domestic market.[10]

Unilever

[edit]

In 1989, Unilever acquired Biocon Biochemicals Ltd. in Ireland and merged it with its subsidiary Quest International. Unilever later sold its holdings to the Indian owners of Biocon Limited in 1998, effectively reuniting the partnered corporations.[11]

Global market

[edit]

During the 2000s, Biocon established its subsidiary Biocon Biologics and substantially grew its production of existing drugs for the American and European markets. Regulatory bodies such as the American Food and Drug Administration and various European state agencies (later the European Commission) have approved Biocon for production of many such products, starting with lovastatin in 2001. Biocon's production largely focused on generics, which as of 2022 had saved European healthcare systems some €30 billion in drug costs.[12]

In the 2010s, Biocon began rapidly expanding its production and market reach. In 2008, Biocon acquired a 70% stake in German pharmaceutical company AxiCorp GmbH.[13] The following year, Biocon established a partnered research facility in Bengaluru with American pharmaceutical corporation Bristol Myers Squibb, and announced a strategic collaboration with Mylan to enter the global generic biologics market.[14][15] The following years saw a steady expansion of major Biocon production facilities in Asian nations, including Malaysia in 2010, and in Bangalone in 2016 with partner Amgen.[16][17]

Novel biopharmaceuticals

[edit]

Simultaneous to its significant increase in global market share, Biocon began increasing its development of biologics, which are more costly and technologically challenging to produce than small molecule drugs. Notable examples include the monoclonal antibodies (mAb) ALZUMAb for psoriasis in 2013,[18] CANMAb to treat breast cancer in 2014,[19] and the ledipasvir-sofosbuvir combination CIMIVIR-L for hepatitis C in 2015.[20]

Biosimilars

[edit]

Much of Biocon's current market share includes biosimilars, licensed versions of existing "innovator" products. Biosimilars are eligible for manufacture and sale after the expiration of the original product's patent protection. These are produced under its subsidiary Biocon Biologics. In 2016, it became the first Indian company to launch a biosimilar insulin glargine pen in Japan.[21] In 2017, USFDA approved Mylan-Biocon's biosimilar for the cancer drug Herceptin.[22] In 2018, Biocon and Mylan received the European Commission's approval to market the biosimilar insulin glargine.[23] In 2022 a Biocon subsidiary, Biocon Biologics, bought the biosimilar assets of Viatris for $3.34 billion.[24] 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.[25] The same year, Biocon Biologics and Serum Institute of India formed a joint agreement to commercialise vaccines, biological drugs, and antibody therapies together.[26] 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.[26] In December 2025, Biocon discontinued its production of the low-cost insulin glargine biosimilar Semglee (insulin glargine-yfgn), causing a significant shortage of basal insulins in the United States as demand moved to other options, in particular Sanofi's Lantus.[27][28]

Corporate governance

[edit]

As of July 2026, Biocon remains chaired by Mazumdar-Shaw.[29][30] Christiane Hamacher was appointed as the CEO of Biocon Biologic India Limited, with her term starting in March 2019.[31] In December 2019, Siddharth Mittal took replaced CEO and managing director Arun Chandavarkar. In 2021, Hamacher resigned from her position, following differences with Mazumdar-Shaw.[32]

Subsidiaries

[edit]

Biocon Biologics

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

Founded in 2000, Biocon Biologics is Biocon's biosimilar subsidiary and largest business component. 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.[33] 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.[33] In May 2022, Viatris sold its biosimilars division to Biocon Biologics for USD $3.335 billion.[34]

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.[35] The company has four divisions: drug discovery services, dedicated research centres, development devices and manufacturing.[35] Syngene works with eight of the top 10 global pharma companies and, Syngene's clients include Amgen, Zoetis, GlaxoSmithKline and Bristol Myers Squibb.[36] 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.[37] Syngene also provides biologics CDMO services.[38] 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.[39] SynVent is Syngene's drug discovery and development platform for both small and large molecules.[40] In September 2022, Biocon divested 5.4% of its shares in Syngene International.[41] Clinigene International Limited is a subsidiary of Syngene offering international pharmaceutical majors Phase I-IV clinical trials and studies for novel/generic molecules.[42]

Other subsidiaries

[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 monoclonal antibodies and cancer vaccines.[42] In 2008, Biocon acquired a majority stake of 70% in AxiCorp GmbH, a German pharmaceutical marketing company.[43] The same year, Biocon started NeoBiocon FZ LLC, a research and marketing pharmaceutical company based in Abu Dhabi.[44] In 2023, Biocon purchased Biofusion Therapeutics Limited.[45]

Strategic partnerships

[edit]

As a major developer and manufacturer in the international drug market, Biocon maintains partnerships with many corporations in the global pharmaceutical market. In 2004, Biocon is began developing human antibodies BVX 10 and BVX-20 with US antibody producer, Vaccinex. BVX 10 targets TNF (Tumor Necrosis Factor) which is expressed at high levels in patients with rheumatoid arthritis.[42] 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.[42] In 2008, Biocon and IATRICa announced a partnership to co-develop immunoconjugates for targeted immunotherapy of cancers and infectious diseases, in particular T cell-mediated immunotherapy.[42] 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.[42] The same year, Biocon signed a collaboration agreement with Viatris to develop and commercialize generic biologics, with Viatris maintaining exclusive commercialisation rights in the USA, Canada, Japan, Australia, New Zealand, EU, and European Free Trade Association countries through a profit-sharing arrangement.[42] 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.[46] Biocon maintains an agreement with Optimer Pharmaceuticals, a biopharmaceutical company focused on the treatment of serious infections such as Clostridioides difficile infection (CDI) for the commercial manufacturing of the antibiotic fidaxomicin.[42]

Facilities

[edit]

Biocon's Indian manufacturing facilities are located at two sites in Bangalore, with several other sites primarily in Asia.[42]

References

[edit]
  1. ↑ "Biocon Annual Report 2017" (PDF). Biocon.
  2. ↑ "Q4 & Full Year FY25 Earnings Presentation" (PDF). Biocon. Retrieved 15 May 2025.
  3. ↑ "Audited financial results (standalone and consolidated) of the Company for the quarter and financial year ended March 31, 2025" (PDF). Biocon. Retrieved 15 May 2025.
  4. 1 2 3 "Biocon Annual Report, 2010" (PDF). Archived from the original (PDF) on 26 October 2010. Retrieved 20 September 2010.
  5. ↑ "Active Pharmaceutical Ingredient (API)". Biocon. 3 July 2020. Retrieved 26 December 2022.
  6. ↑ Plum-Mörschel, Leona; Singh, Gursharan; Murugesan, Sundara Moorthi Nainar; Marwah, Ashwani; Panda, Jayanti; Loganathan, Subramanian; Athalye, Sandeep N. (2022). "Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar Insulin-R with the US -licensed Humulin® R formulation in healthy subjects: Results from the RHINE -1 (Recombinant Human INsulin Equivalence-1) study". Diabetes, Obesity and Metabolism. 24 (4): 713–721. doi:10.1111/dom.14635. ISSN 1462-8902. PMC 9303355. PMID 34981621.
  7. ↑ Egan, Mary Ellen. "Big Shot in Bangalore". Forbes. Retrieved 7 March 2021.
  8. ↑ Katyal, Surabhi (15 June 2015). "6 Indian and Indian Origin Women in the list of Forbes 100 Most Powerful Women in the World". The Better India. Retrieved 21 September 2024.
  9. ↑ "Biocon History". archive.biocon.com. Retrieved 28 July 2026.
  10. ↑ nimmi. "Biocon, India's largest biotech company". www.indianmirror.com. Retrieved 8 February 2018.
  11. ↑ Baisya, Rajat K. (9 September 2010). Winning Strategies for Business. SAGE Publications India. ISBN 9788132106081.
  12. ↑ "The Impact of Biosimilar Competition in Europe 2022". www.iqvia.com. Retrieved 28 July 2026.
  13. ↑ "Biocon Acquires 70% Stake in German Pharmaceutical Company, AxiCorp: Biosimilars Will be Main Focus | Evaluate". www.evaluategroup.com. Retrieved 8 February 2018.
  14. ↑ "Mylan Announces Strategic Collaboration with Biocon to Enter the Global Generic Biologics Market". MediaRoom. Retrieved 8 February 2018.
  15. ↑ Burns, Lawton R. (13 January 2014). India's Healthcare Industry: Innovation in Delivery, Financing, and Manufacturing. Cambridge University Press. ISBN 9781107044371.
  16. ↑ "Biocon Limited To Build US$161 Million R&D Facility in Bio-XCell, Malaysia". Asian Scientist Magazine | Science, technology and medical news updates from Asia. 11 September 2011. Retrieved 8 February 2018.
  17. ↑ "Indian CRO Syngene sets up Amgen R&D center in Bangalore | FierceBiotech". www.fiercebiotech.com. 6 September 2016. Retrieved 8 February 2018.
  18. ↑ "Biocon unveils biologic drug to treat skin disorder". @businessline. Retrieved 8 February 2018.
  19. ↑ "Kiran Mazumdar-Shaw's Biocon develops new breast cancer drug". The Times of India. 18 January 2014. Retrieved 19 January 2014.
  20. ↑ Pilla, Viswanath (24 December 2015). "Biocon launches hepatitis-C drug in India". livemint.com/. Retrieved 8 February 2018.
  21. ↑ Pilla, Viswanath (15 July 2016). "Biocon's partner FUJIFILM launches insulin glargine in Japan". livemint.com/. Retrieved 20 December 2017.
  22. ↑ Trivedi, Isha (2 December 2017). "US FDA approves Mylan-Biocon's biosimilar for cancer drug Herceptin". livemint.com/. Retrieved 8 February 2018.
  23. ↑ "Biocon, Mylan get European Commission approval to market biosimilar insulin glargine". Business Medical Dialogues. 30 March 2018.
  24. ↑ Rajagopal, Divya (1 March 2022). "Biocon's unit buys biosimilar assets of Viatris for $3.34 billion". mint. Retrieved 22 March 2022.
  25. ↑ "Press Release titled "Biocon Biologics and Viatris Inc. Receive Historic Approval for First Interchangeable Biosimilar Semglee® (insulin glargine-yfgn injection) for the Treatment of Diabetes"" (PDF). Biocon.com. 2021. Retrieved 22 March 2022.
  26. 1 2 Das, Sohini (17 September 2021). "Biocon Biologics, Serum Institute Life Sciences enter strategic alliance". Business Standard India. Retrieved 23 March 2022.
  27. ↑ "Drug Shortage Detail: Insulin Glargine Injection (Recombinant)". www.ashp.org. Retrieved 28 July 2026.
  28. ↑ Cueto, Isabella (23 July 2026). "Popular insulin product enters shortage as other pens leave market". STAT. Retrieved 28 July 2026.
  29. ↑ Nature Reviews Drug Discovery, July 2010
  30. ↑ Biospectrum India Friday, 11 July 2008
  31. ↑ "Biocon appoints Christiane Hamacher as CEO of Biocon Biologics India". Medical Dialogues. 2 March 2019.
  32. ↑ "Christiane Hamacher quits as CEO of Biocon Biologics". BusinessLine. 22 January 2021. Retrieved 21 September 2024.
  33. 1 2 Biocon (16 September 2021). "Biocon Biologics and Serum Institute Life Sciences Announce Strategic Alliance". Biocon. Retrieved 23 April 2022.
  34. ↑ Li, Robert (2 March 2022). "Viatris sells biosimilars unit for USD 3.335 billion". ICLG. Retrieved 31 March 2022.
  35. 1 2 Babu, Venkatesha (2021). "We are co-innovating with global pharma companies: Syngene MD & CEO". www.thehindubusinessline.com. Retrieved 15 March 2022.
  36. ↑ Ghosh, Debojyoti (2021). "Syngene's winning formula". www.fortuneindia.com. Retrieved 15 March 2022.
  37. ↑ Rughani, Kushal (10 February 2021). "Initiating Coverage: Syngene International Ltd" (PDF). HDFC Securities. p. 2. Retrieved 22 April 2022.
  38. ↑ Khandekar, Siddhant; Thakur, Raunak (21 January 2022). "Syngene International (SYNINT)" (PDF). ICICI Direct. p. 2. Retrieved 17 May 2022.
  39. ↑ Rautela, Isha (14 July 2022). "Syngene inks 10-year biologics manufacturing pact with Zoetis". www.thehindubusinessline.com. Retrieved 17 July 2022.
  40. ↑ "SynVent Integrated Drug Discovery". Syngene International. Retrieved 24 July 2022.
  41. ↑ Jaiswar, Pooja Sitaram (6 September 2022). "Biocon divests over ₹1,220 crore stake in Syngene International in bulk deal". mint. Retrieved 8 September 2022.
  42. 1 2 3 4 5 6 7 8 9 Biocon Website ("Biocon - Biosimilars, Fermentation, Oral Insulin, Human Insulin, Immunosuppresants, Monoclonal Antibody, Recombinant Proteins, Biopharmaceutical, Biotechnology Company, EGFR, GCSF, Fermentation, Orlistat, Insulin Glargine, Insulin Lispro, Peptides, Insulin Aspart". Archived from the original on 7 August 2014. Retrieved 3 August 2014.)
  43. ↑ "Atlas Copco sells majority stake in rental business". Pump Industry Analyst. 2006 (10): 12. 29 October 2006. doi:10.1016/s1359-6128(06)71621-4. ISSN 1359-6128.
  44. ↑ "Building on a Foundation of IP". www.wipo.int. Retrieved 20 March 2023.
  45. ↑ "Biocon incorporates wholly-owned subsidiary Biofusion Therapeutics". flipit.money. Retrieved 20 March 2023.
  46. ↑ "Sandoz announces exclusive global collaboration with Biocon on next-generation biosimilars | Novartis". Novartis. Retrieved 8 February 2018.
  47. Kiran Mazumdar-Shaw, CMD, Biocon Ltd, 'Biotech Is Not for Punters', Outlook Money, 15 July 2004
  48. Kiran Mazumdar Shaw, India's fermentation queen, 30 August 2001
  49. "How India's Mother of Invention Built an Industry", 16 August 2003
  50. Time, 29 April 2010
  51. The World's 100 Most Powerful Women, Forbes, 19 August 2009
  52. FT top 50 women in world business, Financial Times, 25 September 2009
  53. The Hindu, 12 May 2009
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Further reading

[edit]
  • Bhardwaj, S; De Meyer, Arnoud (2003). "Biocon India". INSEAD Case Study. INSEAD: 12. Reference no. 803-037-1. Retrieved 15 October 2025 – via The Case Centre.
  • Palepu, Krishna G; Chepuri, Ananth (2008). "Biocon Limited". Harvard Business School Case Study. Harvard Business Publishing: 36. Reference no. 9-107-083. Retrieved 15 October 2025 – via The Case Centre.
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