We have evolved from manufacturing pharmaceuticals like statins and immunosuppresants, to discovering, developing and producing biologics in chronic therapies such as diabetes, oncology and immunology for global markets. This has translated into a diversified and differentiated pipeline of fermentation-derived complex generics, biosimilars that include insulins and monoclonal antibodies, and novel biologics.
Biocon is among the few companies globally to have received approvals for its biosimilars from developed countries like the U.S., EU, Australia and Japan. Our credibility as a serious player in the biosimilars sector was first established with the Japanese approval for Insulin Glargine. The credibility was enhanced when Biocon, along with partner Mylan, became the first globally to get biosimilar Trastuzumab and Pegfilgrastim approved in the U.S. in 2017 and 2018, respectively. We were also among the first few to receive Insulin Glargine approval in Europe and Australia for Insulin Glargine, both in partnership with Mylan. We have also established our presence in key emerging markets through safe, effective and high quality biosimilars including recombinant human insulin.
A combination of specialized talent, state-of-the-art research and manufacturing infrastructure and a culture of deep science and regulatory compliance have differentiated us in the marketplace and given us a distinct competitive edge. It has also led to Biocon being recognized as a credible global biopharmaceuticals player.
Commitment to Quality
Biocon’s business is organized into the following reporting segments:
Small Molecules: APIs and Generic Formulations
Over the past few years, we have been investing in diversifying this business by getting into generic finished dosages. We have leveraged our strengths in fermentation technology and product characterization to become a vertically integrated player in the niche space of difficult-to-make generic formulations. As part of our Generic Formulations foray, we have launched Rosuvastatin Calcium formulation in the U.S. and select European markets.
Biologics (Biosimilars & Novel Biologics)
We have partnered our biosimilar portfolio with global generic majors, Mylan and Sandoz, to develop a portfolio for global markets. At the same time, we continue to work independent of these partnerships towards augmenting our portfolio with more biosimilar candidates under development.
We have strong internal R&D capabilities across the entire development continuum spanning clone generation, process and analytical, pre-clinical and clinical development. We also have expertise across the value chain from drug development, CMC to large-scale manufacturing and commercialization. We have made sizable capital investments in building Indiaâ€™s largest bio-manufacturing facilities in Bengaluru and Asiaâ€™s largest Insulins manufacturing complex in Malaysia.
To maintain our leading edge in biosimilars, we have nurtured highly skilled scientific talent and robust R&D infrastructure; been in constant dialogue with key stakeholders to drive biosimilar adoption; sought cost advantages through technology and operational excellence; been ever vigilant on quality and compliance through continuous improvement; and struck strategic partnerships to manage risks and bridge near-term experience gaps.
Lead Novel R&D Assets
We are the pioneers in developing, manufacturing and launching a couple of novel biologics in India, including antibodies like BIOMAb-EGFR®, India’s first indigenously produced novel monoclonal antibody for the treatment of head and neck cancer. We also launched ALZUMAb™, the world’s first novel anti-CD6 monoclonal antibody, in India, for psoriasis. Biocon is the first global company to biologically and clinically validate CD6 as a target for autoimmune diseases.
Biocon is also the first biopharma organization in India to have forayed into the exciting space of (small interfering RNA) siRNA-based therapeutics.
Our Branded Formulations India business has enabled us to carve out a premium niche for ourselves as a biologics-led, specialty products company focused on chronic therapy areas. We are the largest Indian insulins company and one of the leading oncology companies in the country. Some of our key brands are INSUGEN® (rh-insulin), BASALOG® (Glargine), CANMAb™ (Trastuzumab), BIOMAb-EGFR™ (Nimotuzumab), KRABEVA® (Bevacizumab) and ALZUMAb™ (Itolizumab).
Beyond therapy, we support select products with patient friendly initiatives in disease awareness, prevention and management. We also assist healthcare professionals and patients with the treatment of complex medical conditions. This, along with our portfolio approach focused on chronic disease segments, has enabled us to build considerable brand equity for our differentiated products in chronic therapy areas like diabetes, cancer, nephrology, immunology and other life threatening conditions.
Reputed Biotech Employer
Conscientious Corporate Citizen
Our comprehensive CSR policy guides the CSR Committee in overseeing and monitoring the CSR initiatives at Biocon. This Board level Committee ensures that these initiatives follow the course of the larger social vision of the company.
Biocon Limited, publicly listed in 2004, is India’s largest and fully-integrated, innovation-led biopharmaceutical company. As an emerging global biopharmaceutical enterprise serving customers in over 100 countries, it is committed to reduce therapy costs of chronic diseases like autoimmune, diabetes, and cancer. Through innovative products and research services it is enabling access to affordable healthcare for patients, partners and healthcare systems across the globe. It has successfully developed and taken a range of Novel Biologics, Biosimilars, differentiated Small Molecules and affordable Recombinant Human Insulin and Analogs from ‘Lab to Market’. Some of its key brands are INSUGEN® (rh-insulin), BASALOG® (Glargine), CANMAb™ (Trastuzumab), BIOMAb-EGFR™ (Nimotuzumab) and ALZUMAb™ (Itolizumab), a ‘first in class’ anti-CD6 monoclonal antibody. It has a rich pipeline of Biosimilars and Novel Biologics at various stages of development including Insulin Tregopil, a high potential oral insulin analog.
Biocon’s consolidated revenue for FY 16 stands at Rs 35,699 million (USD 525 million). Biocon is focused on attaining a size of USD 1 billion by 2018.
Biocon has over 8,000 employees.
To enhance global healthcare through innovative and affordable biopharmaceuticals for patients, partners and healthcare systems across the globe
To be an integrated biotechnology enterprise of global distinction.
Essential to this mission is excellence in:
– Intellectual asset creation through discovery, research and development
– State-of-the-art manufacturing capabilities
– Internationally benchmarked quality and regulatory systems
– New medical insight through disease specific
– Customer relationship through outstanding products
– Human resource development through training,
– Management of research and business partnerships
– Integrity and Ethical Behaviour
– Performance driven work culture
– Value Creation through Innovation & Differentiation
– Quality through Compliance & Best Practices
– Collaboration, Team Work & Mutual Respect
November 29, 1978
Biocon’s Founding Day - the start of a biorevolution in India. Over the years, Biocon has evolved from an enzyme-manufacturing company into a fully integrated biopharmaceutical enterprise. Today, we leverage a formidable combination of proprietary fermentation technologies and research skills to develop affordable therapy for unmet medical needs.
Biocon India is incorporated as a joint venture between Biocon Biochemicals Ltd. of Ireland and an Indian entrepreneur, Kiran Mazumdar-Shaw
Biocon is the first Indian company to manufacture and export enzymes to USA and Europe
Unilever plc. acquires Biocon Biochemicals Ltd. in Ireland and merges it with its subsidiary, Quest International
Biocon is the first Indian biotech company to receive US funding for proprietary technologies
Biocon scales up its in-house research programme, based on a proprietary solid substrate fermentation technology, from pilot to plant level
Biocon's R&D and manufacturing facilities receive ISO 9001 certification from RWTUV, Germany
Biocon establishes Syngene International Pvt. Ltd. as a Custom research Company (CRC) to address the growing need for outsourced R&D in the pharmaceutical sector
The commercial success of Biocon's proprietary fermentation plant leads to a 3-fold expansion
Biocon leverages its technology platform to enter biopharmaceuticals and statins
Biocon spearheads initiatives in human healthcare through a dedicated manufacturing facility
Unilever inks a deal with ICI to sell its specialty chemicals division of which Quest International is a part. Unilever agrees to sell its shareholding in Biocon to the Indian promoters. Biocon becomes an independent entity
Biocon commissions its first fully automated submerged fermentation plant to produce specialty pharmaceuticals
Biocon establishes Clinigene, India's first Clinical Research Organisation (CRO) to pursue clinical research and development
Biocon becomes the first Indian company to be approved by US FDA for the manufacture of lovastatin, a cholesterol-lowering molecule
Biocon's proprietary bioreactor, PlaFractor™ is granted a US 2001 and world-wide patent
Clinigene's clinical laboratory is the first in India to receive CAP accreditation
Biocon is the first company worldwide to develop human insulin on a Pichia expression system
Biocon creates a buzz in the stock market in March 2004 with its hugely successful IPO. Day 1 on the bourses closes with a market value of $1.11 billion, making Biocon only the second Indian company to cross the $1 billion mark on the first day of listing.
Syngene establishes new research centre
Biocon Limited, announced the launch of INSUGEN®, the new generation bio-insulin, manufactured in Asia's largest human insulin plant.
Biocon Limited and Vaccinex, Inc. announce a broad strategic partnership to discover and co-develop at least four therapeutic antibody products.
Biocon signs a commercial agreement for supply of insulin API to Asia, Africa and the Middle East.
Biocon inaugurates Biocon Biopharmaceuticals, India's largest multi-product Biologics facility at Biocon Park
Biocon inaugurates Biocon Park, India's largest integrated biotechnology hub, comprising an integrated cluster of research laboratories and manufacturing facilities spread across 90 acres in KIADB (Karnataka Industrial Areas Development Board) industrial estate.
Biocon announced a licensing agreement with Bayer HealthCare (BHC) for the exclusive marketing and trademark rights for INSUGEN® for the Chinese market.
Syngene and Innate Pharmaceuticals AB, Umea, Sweden conclude a cooperation agreement to jointly develop, manufacture and market virulence blockers to counteract bacterial diarrhoeal disease.
Biocon launches India's first anti-cancer drug BIOMAb EGFR®.
Biocon and Abu Dhabi based pharmaceutical company Neopharma sign an MOU to establish a JV to manufacture and market a range of biopharmaceuticals for the GCC countries (Gulf Cooperation Council).
Biocon grants exclusive license to Ferozsons Laboratories Limited for marketing BIOMAb EGFR® in Pakistan.
Biocon announced the launch of its Nephrology Division and a comprehensive portfolio of renal therapy products.
Syngene enters into a research partnership with Bristol-Myers Squibb and completes the ground breaking ceremony of new research facility at Biocon Park.
Biocon signs Memorandum of Understanding with Deakin University, Australia. To establish Deakin Research Institute in Bangalore
Biocon divests enzymes division for USD 115 million to Novozymes. Biocon business portfolio to focus on biopharmaceuticals
Biocon and Abraxis BioScience, announce an agreement wherein Abraxis will license the right to develop a biosimilar version of G-CSF (Granulocyte-Colony Stimulating Factor) in North America and the European Union.
Biocon and Neopharma sign an MoU to establish Neobiocon, a joint venture company in Dubai's biotechnology and research park, Dubiotech.
Biocon acquires a 78% stake in German pharmaceutical company, AxiCorp GmbH for a consideration of €30 Million
Biocon launches a Safety Device in the form of pre-filled syringes for two of its life saving products, GCSF (granulocyte-colony stimulating factor) and EPO (Erythropoietin) in collaboration with Safety Syringes Inc. ERYPRO Safe™ and NUFIL Safe™ are the first two drugs that will marketed using this novel device with other injectable products to follow in the future.
Biocon is ranked among the top 20 global biotechnology companies (Med Ad News).
Biocon is the 7th largest biotech employer in the world (Med Ad News).
Biocon announced the results of an ascending dose study on its oral insulin drug (IN-105) at the European Association for the Study of Diabetes (EASD) meeting in Rome.
Biocon's Syngene partners with Sapient Discovery to expand integrated drug discovery offerings
Biocon's Syngene and DuPont Crop Protection Forge Alliance Partnership
Bristol-Myers Squibb and Biocon's Syngene open new R&D Facility at Biocon Park
Biocon launches BASALOG - long lasting basal insulin for Type 1 & Type 2 Diabetics
Biocon inks partnership with ISB to launch the Biocon Cell for Innovation Management
Biocon announced Strategic Collaboration with Mylan to enter the Global Generic Biologics Market
Biocon Limited and Amylin Pharmaceuticals entered into a Global Development and Commercialization Agreement for a Novel Peptide Hybrid. The Program will focus on the potential treatment of diabetes.
Biocon and HCG group of hospitals join hands to fight against cervical
Biocon explores investment in Malaysia in partnership with BiotechCorp
Biocon and Bayer join hands to create awareness for self monitoring for diabetics
Syngene and Endo Pharmaceuticals, USA to jointly discover and develop novel biological drug molecules to fight cancer
Biocon acquires stake of its Cuban partner CIMAB S.A. in their seven year old JV, Biocon Biopharmaceuticals Pvt. Ltd
Biocon and Optimer Pharmaceuticals announce manufacturing and supply agreement for a novel API, first-in-class anti-infective (C. difficile)
Biocon and the Center of Molecular Immunology (CIM), based in Havana, Cuba strengthen their existing research partnership by joining forces for an integrated antibody program in immunology
Biocon announced a strategic foreign direct investment in Malaysia with the Malaysian Biotechnology Corporation SdnBhd (BiotechCorp)
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 announced project commencement for first high-end biopharmaceutical manufacturing and R&D facility in Bio-XCell, Malaysia
Biocon launches INSUPen®, a convenient and affordable reusable insulin delivery device
Biocon announced Positive Results from its Global Phase 3 study with Recombinant Human Insulin
GE Capital invests in Syngene, Biocon's Research Services Subsidiary
Biocon announced Positive Efficacy Data from Phase 3 clinical study with its Novel Monoclonal Antibody, Itolizumab for Psoriasis
Syngene - a subsidiary of Biocon Group, in collaboration with Abbott, setup a dedicated Nutrition Research and Development Center at Biocon Park
Biocon announced positive results from its Phase 1 Comparative PK-PD Study with Biosimilar Insulin Glargine
Biocon: the only Asian Company to Feature in the Global Top 20 BioPharma Employers, by Science Magazine
Biocon enters into an agreement with Bristol-Myers Squibb for its IN-105, an Oral Insulin drug
Biocon received Marketing Authorization from the Drugs Controller General of India (DCGI) for its Novel Biologic Itolizumab, anti CD6 molecule, for the treatment of chronic plaque Psoriasis
Biocon enhances Partnership with Mylan through Strategic Collaboration for Insulin Products
Biocon Delivers a Healthy Growth of 22% driven by strong traction in Biopharma
Biocon Launched ALZUMAb™- a 'First in Class' Novel Biologic Treatment for Psoriasis Patients in India
Biocon Partnered with CytoSorbents to Market CytoSorb® - A 'First-in-Class' Therapy for Sepsis Management
Biocon Ranked at No. 6 among Top 20 Global Biotech Employers by the Science Magazine
Biocon Unveils Biocon Academy - A Center of Excellence for Advanced Learning in Applied Biosciences
Biocon & Mylan received Indian Regulatory Approval for Trastuzumab for Treating Breast Cancer
Biocon and Quark Pharmaceuticals Collaborate to Develop Novel siRNA based Therapeutics
Biocon's ALZUMAb™ wins BioSpectrum BioPharma Product of the Year, 2013
Biocon Academy's Flagship Program in Collaboration with KGI Takes Off to a Flying Start
Biocon has been conferred with the Sir J C Bose Memorial Award – 2013 (Institutional category) by Indian Science Monitor (ISM) for its contribution in the field of Biotechnology, with special reference to the launch of ALZUMAb (Itolizumab)
Biocon introduced CANMAb™ - Trastuzumab for Treating Breast Cancer in India
Syngene, a subsidiary of Biocon Group, in collaboration with Baxter sets up a dedicated Research and Development Center at Biocon Park
Silver Leaf Oak (Mauritius) Limited, an investment vehicle advised by India Value Fund Advisors has agreed to acquire a minority 10% stake in Syngene International Limited, Biocon's Research Services subsidiary. Silver Leaf will acquire the stake from Biocon Research Limited, a wholly owned subsidiary of Biocon Limited at a valuation of Rs.3800 Crore
Biocon Expands its Strategic Partnership with CytoSorbents for CytoSorb® to Treat SIRS and Cardiac Surgery Patients
Biocon Foundation Recognized for Outstanding Contribution to Public Health by WHO -India
Biocon Strengthens its Presence in Mexico; Receives Approval for Insulin Glargine through its partner PiSA Farmaceutica
Biocon's CRO Arm Syngene Seeks Approval for IPO, Files DRHP; Offer allows Biocon to monetize its shareholding in Syngene
Biocon-Mylan Programs Make Progress: PEG-G-CSF and Adalimumab enter Phase 3 clinical trials; Patient recruitment for one Insulin Glargine Phase 3 study completed
Biocon's Biosimilars Programs Make Progress; One of the Largest Generic Insulin Analogs and Biosimilars Portfolio in Advanced Stages of Development
Biocon's CRO Arm Syngene Lists on BSE and NSE; Valued at $1 billion on Market Debut
Biocon Inaugurates World Class Devices Facility in Bangalore & Introduces Basalog One™ in India
Biocon is the Only Asian Company to be Ranked Among Top 20 Global Biotech Employers for 2015
Journal of the American Medical Association (JAMA) Publishes Mylan and Biocon's Proposed Biosimilar Trastuzumab Phase 3 Data
Biocon Features in Asia IP Elite 2016 List
Biocon's Novel Diabetes Education Initiative for Medical Practitioners 'ABIDE' Awarded by RSSDI
Mylan and Biocon Announce U.S. FDA Submission for Proposed Biosimilar Trastuzumab
Mylan and Biocon Announce Regulatory Submission for Insulin Glargine Accepted for Review by European Medicines Agency
Biocon Ranked Among Global Top Ten Biotech Employers; The only Asian Company to Feature in 2016 Rankings
Mylan & Biocon Announce Regulatory Submission for Proposed Biosimilar Pegfilgrastim Accepted for Review by European Medicines Agency
Biocon's Insulin Glargine Launched in Japan
Biocon, Quark Announce Initiation of Pivotal Phase II/III Study of QPI-1007 in Rare Eye Disease in India
Mylan and Biocon to Present Phase 3 Trastuzumab Biosimilar Data at the American Society of Clinical Oncology (ASCO) Annual Meeting
Biocon Announced Data from Key Studies for Insulin Tregopil
Biocon Gets its First Generic Formulation Approval in EU; On Track to Launch Rosuvastatin Tablets in FY17
Biocon Inks Co-Development & Commercialization Agreement with Lab PiSA for rh- Insulin in USA
Biocon's Insulin Glargine Receives Regulatory Approval in Japan
U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Pegfilgrastim for Review
Biocon started commercial operations at its Malaysia facility with the MYR 300 Million Contract from MoH, Malaysia to supply rh-insulin
U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Trastuzumab
Biosimilar Bevacizumab launched as KRABEVA® for patients of various types of cancer in India
U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) votes unanimously (16-0) for the approval of our biosimilar Trastuzumab in July 2017
Biocon and partner Mylan became the first companies globally to receive U.S. FDA approval for biosimilar Trastuzumab. Ogivri™ (trastuzumab-dkst) is the first biosimilar from Mylan and Biocon’s joint portfolio approved in the U.S.
Biocon is the first Indian company to receive a U.S. FDA approval for a biosimilar
The EMA's Committee for Medicinal Products for Human Use (CHMP) recommends for approval the Insulin Glargine co-developed by Biocon and Mylan in January 2018
The European Commission approves the sale of biosimilar Insulin Glargine, Semglee™ 100 units/mL 3 mL prefilled disposable pen, in March 2018
Therapeutic Goods Administration, Australia approves biosimilar Insulin Glargine, Semglee™ 100 IU/mL 3 mL prefilled pen, for people with diabetes in Australia
The U.S. FDA approves Fulphila™, a biosimilar Pegfilgrastim co-developed by Biocon and Mylan, in June 2018
Fulphila™, co-developed by Biocon and Mylan, becomes the first biosimilar Pegfilgrastim launched in U.S.
Biocon is first Company from India to commercialize a biosimilar in the U.S.
"We advocate transparency and open channels of communication within the organisation and externally".