Biocon India Private Limited is incorporated as a joint venture between Kiran Mazumdar-Shaw and Biocon Biochemicals Limited, Ireland. Starting with three employees in a tin-roofed shed in Bangalore (the office, laboratory and manufacturing space), Biocon began manufacturing and export of Papain, a plant enzyme, and Isinglass, a marine hydrocolloid – both, key products for the brewing industry.
Biocon is the first Indian company to manufacture and export food processing enzymes to the US and Europe, signaling the company's ambition to produce high quality, world class products in India for global markets.
Biocon acquires a 20-acre plot on Hosur Road for INR 600,000 to expand operations. On March 8, 1980, the foundation stone was laid for the building that currently houses the company’s corporate office.
Biocon establishes itself as a well-respected global enzymes player, with market leadership in several niche applications.
Biocon decides to move beyond just exporting extracts to Ireland and establishes its identity and organizational culture around research & development. Biochemizyme India Ltd. is incorporated as an independently funded R&D unit, to advance the company's enzyme technologies.
Biocon’s new campus at 20th KM, Hosur Road, Electronics City, Bangalore is inaugurated. As enzyme exports grew, manufacturing activity shifted from the garage to the new site.
Biocon began focusing on research & development to develop novel enzymes through a solid-state fermentation process technology referred to as 'Koji' technology, which required small-sized bioreactors, less water and less energy.
Biocon Biochemicals Ltd, Ireland and its subsidiaries are acquired by Quest International of the Netherlands, a wholly-owned subsidiary of Unilever. Biocon India begins producing enzymes for Unilever’s food business.
Biocon becomes the first Indian biotech company to receive US funding for proprietary technologies.
Biocon scales up its in-house research program based on a proprietary solid substrate fermentation technology, from pilot to plant level. Biochemizyme, the first commercial solid state fermentation plant is commissioned
Biocon's R&D and manufacturing facilities receive ISO 9001 certification from RWTUV, Germany
Syngene is incorporated as a Custom Research Organization (CRO) in 1993, to provide efficient, high-quality, cost-effective research & development services in chemistry and biology to third party clients.
Unilever acquires 50% of the shares in Biochemizyme and also acquires shares in Biocon. Biocon Quest India Ltd (BQIL) is established with Biocon and Unilever acquiring around 50% stake each.
Biocon enters the biopharmaceuticals space with the development of statins, based on its proprietary fermentation technology.
Biocon starts a dedicated manufacturing facility, Helix Biotech, which is involved in the manufacturing of pharma bulk actives.
Biocon becomes an independent, privately owned entity, with 80% of its business in enzymes and 20% in biopharmaceuticals.
Novel Laureat Prof. James D. Watson visits Biocon on January 9, 1999
Biocon establishes Clinigene as India's first Clinical Research Organisation to develop world-class capabilities for clinical research and related activities.
Biocon is the first Indian company to be approved by US FDA for the manufacture of Lovastatin API.
Biocon’s proprietary bioreactor, PlaFractor is granted a US 2001 and worldwide patent.
Biocon establishes a joint venture company, Biocon Biopharmaceuticals Pvt Ltd, with CIMAB S.A., a Cuban biotechnology company, to produce and sell biologicals developed by CIMAB, including erythropoietin and filgrastim into the Indian market.
Clinigene becomes the first company in India to receive certification from the College of American Pathologists, or CAP.
Biocon files its 100th patent application.
Biocon is the first company worldwide to develop recombinant human insulin (rh-insulin) on a Pichia expression system. Today, Insugen® is the largest generic insulin brand in India.
Biocon is the first Indian insulin producer to submit a drug master file (DMF) for rh-insulin to the U.S. Food and Drug Administration
Biocon creates a buzz in the stock market in March 2004 with its hugely successful IPO. The IPO received bids five times the 1 crore shares available for subscription within an hour of opening of the bidding process. On Day 1 of listing on the bourses, Biocon closes with a market value of USD 1.11 billion, making Biocon only the second Indian company to cross the USD1 billion mark on the first day of listing.
Biocon and U.S. biotech company Vaccinex Inc. announce a broad strategic partnership to discover and co-develop therapeutic antibody products.
Biocon Park, India’s first private corporate biotechnology SEZ, becomes operational.
External Link to Address by Dr APJ Abdul Kalam during Inauguration of Biocon Park
Biocon earns the distinction of being the first company in India to launch a novel biologic, Nimotuzumab, for head and neck cancer patients. Through the introduction of this molecule as BIOMAb EGFR® Biocon enhanced the treatment outcome as well as quality of life of cancer patients in India.
Biocon and Abu Dhabi-based pharmaceutical manufacturer Neopharma set up Neobiocon, a joint venture company to provide affordable life-saving drugs to the people of UAE.
Biocon divests its enzymes business to Novozymes for USD115 million. The sale funded the company’s joint venture with Cuban institute CIMAB to build a mammalian cell manufacturing facility, Biocon Biopharmaceuticals Private Limited.
Biocon acquires a 70% stake in German pharmaceutical company, AxiCorp GmbH, for a consideration of EUR30 million, enabling the marketing and distribution of a range of pharmaceuticals in Germany and Europe.
Biocon launches Insulin Glargine, a long-acting insulin analog in India under the brand name BASALOG®.
Biocon’s partners with US-based Mylan for the co-development of a high-value portfolio of biosimilars for oncology and autoimmune indications. The portfolio consists of three monoclonal antibodies — trastuzumab, bevacizumab and adalimumab — and two recombinant proteins — pegfilgrastim and etanercept. Later, the two companies also add filgrastim to the co-development portfolio.
Biocon acquires the stake held by its joint venture partner CIMAB in Biocon Biopharmaceuticals Pvt Ltd (BBPL). Both the companies, however, continue their partnership on research, development and commercialisation of novel biopharmaceutical products.
Biocon announces one of the biggest investments in the Malaysian biotechnology sector for the setting up of an integrated insulins manufacturing and research & development facility at Johor.
Biocon and Pfizer enter into a strategic global agreement for the worldwide commercialization of Biocon's biosimilar versions of Insulin and Insulin analog products: Recombinant Human Insulin, Glargine, Aspart and Lispro.
Biocon and Optimer Pharmaceuticals enter into a long-term supply agreement for the commercial manufacturing of the API fidaxomicin.
Biocon launches Evertor, the first generic of everolimus in India, indicated for the treatment of patients with advanced renal cell carcinoma.
Biocon begins selling a convenient, affordable and reusable insulin pen, INSUPen®, for patients in India.
Biocon divests its stake in its German subsidiary, AxiCorp GmbH, to the existing group of promoter shareholders. AxiCorp was the licensee for Biocon's biosimilar Insulin and Glargine in Germany, and had the sole responsibility for commercializing these products. As a consequence of this divestment, these rights revert to Biocon.
Biocon enters into an option agreement with Bristol-Myers Squibb (BMS) for its oral insulin drug candidate that provides for ﬁnancial, strategic and developmental assistance from BMS while Biocon continues the development of the asset through Phase II. At the end of Phase II trials, BMS will have an exclusive option to further develop and commercialize the asset worldwide. In the eventuality that BMS does not exercise the option, Biocon retains the right to ﬁnd a different partner to take the program forward.
Biocon and Pfizer end their alliance to commercialize Biocon’s biosimilar versions of recombinant human insulin and three insulin analog products, Glargine, Lispro and Aspart. All rights licensed to Pfizer for these insulin molecules revert to Biocon.
Biocon enters into an exclusive strategic collaboration with Mylan for the global development and commercialization of biosimilar versions of its three insulin analog products, Glargine, Lispro and Aspart.
Biocon launches Itolizumab, a novel first-in-class humanized anti-CD6 monoclonal antibody approved for treating psoriasis, under the brand name ALZUMAb™ in India. This is the ﬁrst anti-CD6 monoclonal antibody in the world to be commercialized, which makes it a path breaking innovation to come out of an Indian laboratory.
Biocon ties up with Quark Pharmaceuticals for the development of siRNA- based (small interfering RNA) novel therapeutics. The partnership helps Biocon access Quark’s platform technology for jointly developing the lead molecule in the pipeline, QPI-1007. This molecule is being investigated for ocular neuro-protection in NAION (non-arteritic anterior ischemic optic neuropathy). Biocon is the first biopharma organization in India to have forayed into the exciting space of siRnA-based therapeutics.
Biocon receives marketing authorization from the Drugs Controller General of India (DCGI) for its biosimilar Trastuzumab developed jointly with Mylan for the treatment of HER2-positive metastatic breast cancer. It is the first biosimilar Trastuzumab to be approved anywhere in the world.
Biocon and U.S.-based CytoSorbents Corp enter into a strategic partnership with an initial distribution agreement for India and select emerging markets, under which Biocon will have the exclusive commercialization rights for CytoSorb®, a novel therapy for the management of sepsis.
Biocon establishes Biocon Academy as a learning initiative under its Corporate Social Responsibility (CSR) agenda to address the skill deficit in the Indian biotech industry and enhance the employability quotient of life sciences graduates
Biocon introduces of CANMAb™ in India as the world’s lowest priced Trastuzumab, opening the doors for HER2-positive metastatic breast cancer patients to access an affordable therapy.
Biocon’s research services subsidiary, Syngene, debuts on the Indian stock market. Syngene’s market capitalization crossed USD 1 billion within a week of listing.
Biocon inaugurates a state-of-the-art 100,000 square feet facility in Bangalore for manufacturing new generation, patient-friendly devices for its insulins portfolio.
Biocon's product becomes the first biosimilar Insulin Glargine to be approved in Mexico as per the country’s biologics approval pathway. Biocon’s long- standing partner, Laboratorios PiSA, launched Insulin Glargine under the brand name Galactus.
Biocon launches Basalog One™, a high-end, pre-filled Insulin Glargine pen that is almost painless, safe and convenient to administer.
Biocon receives European approvals for its generic Rosuvastatin Calcium tablets, which is indicated for hyperlipidemia or mixed dyslipidemia. This is Biocon's first generic formulations approval in the regulated markets and marks an important milestone in the company's small molecules strategy of forward integration from APIs to finished dosages. Biocon is the first generic company to receive a Certificate of Suitability (CEP) for Rosuvastatin Calcium API from the European Directorate for the Quality of Medicines (EDQM). A CEP certification indicates that an API is suitable for use in medicinal products in the EU.
Biocon enters into a strategic agreement with Mexican partner Laboratorios PiSA for the development and commercialization of its recombinant human Insulin (rh-Insulin) for the U.S. market. This collaboration will enable Biocon to manufacture the rh-Insulin drug product at PiSA’s facilities in Mexico and commercialize it under Biocon’s brand in the US market.
Biocon achieves a major regulatory milestone with Japan's health regulator approving the sale of its biosimilar Insulin Glargine partnered locally with FUJIFILM Pharma. This is Biocon’s first biosimilar approval in a developed market and the first biosimilar from a company in India to be approved in Japan.
Biocon announces positive data on oral insulin candidate, Insulin Tregopil, following Phase I clinical studies conducted in the U.S. under a U.S. IND, initiated in partnership with Bristol-Myers Squibb (BMS) prior to their divestment of the diabetes franchise to AstraZeneca. The studies validate and provide the basis for the next phase of clinical development of this important molecule.
Biocon starts commercial operations at its first overseas insulins manufacturing facility in Malaysia. Biocon’s rh-Insulin is the first locally manufactured biosimilar product to be approved for sale by the National Pharmaceutical Regulatory Authority (NPRA), Malaysia.
Equillium Inc. acquires U.S. and Canadian rights to Itolizumab, through an exclusive collaboration and license agreement with Biocon.
Biocon successfully launches its biosimilar Bevacizumab in India as KRABEVA® for patients of various types of cancer. KRABEVA®, the second oncology biosimilar launched in India after CANMAb (Trastuzumab), is prescribed for metastatic colorectal cancer (mCRC) and several other types of lung, kidney, cervical, ovarian and brain cancers.
Biocon and Mylan create history by becoming the first companies globally to receive U.S. Food and Drug Administration (FDA) approval for biosimilar Trastuzumab. Ogivri™ (trastuzumab-dkst) is the first biosimilar from Biocon and Mylan’s joint portfolio approved in the U.S. and Biocon is the first Indian company to receive a U.S. FDA approval for a biosimilar. The approval followed the U.S. FDA’s Oncologic Drugs Advisory Committee's (ODAC) unanimous (16-0) vote recommending the approval of Biocon and Mylan's biosimilar Trastuzumab in July 2017..
Biocon achieves another milestone with the approval and launch in the U.S. of Fulphila™, biosimilar Pegfilgrastim co-developed with partner Mylan. Biocon is the first company from India to have a biosimilar commercialized in the U.S.
Biocon and Mylan are among the first few companies globally to receive approval for biosimilar Insulin Glargine in Europe after the European Commission approves the sale of Semglee™ pre-filled disposable pens. Semglee™ is the first biosimilar from Biocon and Mylan’s joint portfolio to be approved in Europe. The approval follows a positive opinion issued by European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).
Biocon and Mylan receive approval from the Therapeutic Goods Administration, Australia for the sale of biosimilar Insulin Glargine as Semglee™ prefilled disposable pens.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issues a positive opinion recommending approval of Fulphila®, biosimilar Pegfilgrastim co-developed with partner Mylan.
Biocon enters into a global partnership with Sandoz, a Novartis division and a global player in biosimilars to develop a next-generation biosimilars portfolio, which will help patients worldwide gain access to a range of high quality, affordable immunology and oncology biologics.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issues a positive opinion recommending approval of Ogivri®, biosimilar Trastuzumab co-developed with partner Mylan.
Fulphila®, a biosimilar Pegfilgrastim jointly developed by Biocon and Mylan, is granted Marketing Authorization by the European Commission.
Ogivri®, a biosimilar Trastuzumab jointly developed by Biocon and Mylan, is granted Marketing Authorization by the European Commission.
Biocon's partner Equillium receives a 'fast track' designation from the U.S. Food & Drug Administration for EQ001, or Itolizumab, for the treatment of acute graft-versus-host disease (aGVHD).
Semglee® is launched in EU by our partner Mylan.
Ogivri, co-developed by Biocon and Mylan, is the first biosimilar Trastuzumab to be approved in Canada for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer.
Ogivri, co-developed by Biocon and Mylan, is the first biosimilar Trastuzumab to be approved and launched in Australia for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer.
Bicara Therapeutics is incorporated as a wholly owned subsidiary of Biocon in Boston, U.S., to focus on developing a pipeline of bifunctional antibodies that exploit the recent advances in immuno-oncology.
Biocon Biologics is set up to consolidate the development, manufacturing and commercialization operations for biosimilars under an independent entity, with its own dedicated management.