Milestones & Legacy
2025
Entered into strategic agreement with Civica Inc. to expand Insulin Aspart access in the U.S.
Launched Yesintek™ (bUstekinumab), a biosimilar to Stelara®, in the U.S.
2024
Refinanced USD 1.1 Billion long-term debt through USD bonds and new syndicated facility.
Became the first company to get U.S. FDA approval for interchangeable bAflibercept.
Entered into a long-term commercial collaboration with Eris Lifesciences to enhance the footprint of its commercial product brands in India.
2023
Partnered with Sandoz for the Distribution of Adalimumab BS Subcutaneous Injection [FKB] in Japan
Successfully completed the integration of the acquired biosimilars business across 120+ countries.
Launched Hulio® (biosimilar Adalimumab) injection in the U.S. for patients with certain inflammatory diseases.
2022
Successfully completed the strategic, multi-billion-dollar acquisition of its long-term partner Viatris’ global biosimilars business.
2021
Received an equity investment of USD 75 million from Abu Dhabi-based ADQ, one of the region’s largest holding companies.
Joined hands with the Clinton Health Access Initiative (CHAI) to expand access to lifesaving cancer biosimilars in over 30 countries in Africa and Asia as a part of the Cancer Access Partnership (CAP).
Received a historic U.S. FDA approval for Semglee® (biosimilar Insulin Glargine) as the world’s first ‘interchangeable’ biosimilar product.
2020
Successfully commercialized Semglee® in the U.S., becoming the first company from India to launch biosimilar Insulin Glargine in the U.S.
Secured a total investment of USD 255 million through separate agreements with True North, Tata Capital, and Goldman Sachs to expand R&D and manufacturing capabilities, and drive business growth.
2019
Biocon Biologics Limited was set up as an independent entity with its own dedicated management team to spearhead the R&D, manufacturing, and commercialization operations of Biocon’s Biosimilars business.
Successfully commercialized Ogivri® in the U.S., becoming the first Indian company to launch biosimilar Trastuzumab in the market.
Semglee® and Ogivri® were the first biosimilar Insulin Glargine and biosimilar Trastuzumab, respectively, to be made available in Australia through the Pharmaceutical Benefits Scheme.
Ogivri® received a nod from Health Canada as the first biosimilar Trastuzumab to be approved in the country.
2018
The approval and launch of Fulphila® (biosimilar Pegfilgrastim) in the U.S. made Biocon the first company from India to commercialize a biosimilar product in the market.
Semglee®, a biosimilar Insulin Glargine, becomes the first biosimilar insulin from Biocon’s portfolio to be approved for commercialization in Europe.
Fulphila®, a biosimilar Pegfilgrastim, and Ogivri®, a biosimilar Trastuzumab, were granted marketing authorization in the EU.
2017
Achieved the distinction of being the first company globally to receive U.S. FDA approval for biosimilar Trastuzumab; and the first company from India to receive regulatory nod for a biosimilar in the U.S.
Commenced commercial operations at Biocon’s first overseas insulins manufacturing facility in Malaysia.
Successfully received approval from the Brazilian regulator ANVISA for biosimilar Trastuzumab, making it the first biosimilar Trastuzumab to be approved in the country.
2016
Became the first company from India to commercialize a biosimilar in Japan, following the regulatory approval of Insulin Glargine in the market.
2015
Inaugurated a 100,000 sq ft facility for manufacturing new-generation, patient-friendly insulin devices in Bengaluru, and launched Basalog ONE®, a high-end, prefilled Insulin Glargine pen, in India.
2014
Launched CANMAb® in India; the first biosimilar Trastuzumab to be approved anywhere in the world.
2013
Expanded an existing biosimilars partnership with Viatris (formerly Mylan) to develop a portfolio of insulin analogs.
Launched ALZUMAb® (Itolizumab), the world’s first novel anti-CD6 monoclonal antibody, for psoriasis in India.
2012
Biocon Research Centre, a 200,000 sq ft, state-of-the-art facility, was inaugurated to accelerate a culture of innovation and frontier research.
2011
Launched INSUPen®, a reusable insulin delivery device designed for the efficient, accurate and safe delivery of Basalog® and Insugen®, in India, marking a foray into devices.
2009
Partnered Viatris (formerly Mylan) to co-develop high-value biosimilars for oncology and autoimmune indications, marking one of the earliest partnerships in the global biosimilars space.
Launched Basalog® (biosimilar Insulin Glargine) in India, expanding its insulin portfolio and providing diabetes patients access to an advanced and affordable insulin analog.
2007
Divested legacy enzymes business to Novozymes for US$115 million.
2006
Biocon Park, India’s largest integrated biotechnology hub spread across 90 acres, inaugurated in Bengaluru by former President of India Dr A.P.J. Abdul Kalam.
Biocon commercializes India’s first indigenously produced novel mAb, BIOMAb EGFR® (Nimotuzumab) for the treatment of head and neck cancer.
2004
Commercialized Insugen® in India as the world’s first and only Pichia Pastoris-derived recombinant human insulin.
A hugely successful IPO made Biocon the second Indian company ever to cross the US$1 billion mark on the first day of listing.
2002
Forays into the development of antibodies using mammalian cell-based expression systems through a joint venture with CIMAB S.A., a Cuban biotechnology company.
2000
Biocon makes its foray into biopharmaceuticals and begins building specialized capabilities to harness a future in biosimilars.
PlaFractor™, its patented fermentation reactor, enables Biocon to become the first company to produce the immunosuppressant, mycophenolate mofetil, using this technology.
A fully automated, submerged fermentation plant is commissioned to produce specialty biopharmaceuticals.
1995
Solid-state fermentation capacity expands four-fold to produce a range of fungal enzymes for the food and pharmaceutical industry.
1993
Biocon becomes the first life sciences company out of India to receive ISO 9001 certification from RWTUV, Germany, for its R&D and manufacturing facilities.
1990
Research program based on proprietary solid-state fermentation technology scales up from pilot to plant level.
1984-89
An R&D division focused on solid state fermentation technology is established to drive research in novel enzymes. Within 5 years, Biocon begins producing enzymes for Unilever’s food businesses.
1983
A state-of-the-art integrated campus, spread over 20 acres, is commissioned to house Biocon’s manufacturing facilities and corporate office.
1979
Exported papain, a plant enzyme derived from papaya, to U.S. and Europe, signalling the company’s ambition to produce high quality, world class products in India for global markets.
1978
Biocon India Pvt. Ltd. is incorporated as a joint venture between Kiran Mazumdar-Shaw and Biocon Biochemicals Ltd. Ireland.
