Biocon Limited is India's largest and fully-integrated innovation-led biopharmaceutical company. Some of its key brands are INSUGEN (rh-insulin) BASALOG (Glargine) CANMAb (Trastuzumab) BIOMAb-EGFR (Nimotuzumab) KRABEVAA (Bevacizumab) and ALZUMAb (Itolizumab) a 'first in class' anti-CD6 monoclonal antibody. The company has a rich pipeline of Biosimilars and Novel Biologics at various stages of development including Insulin Tregopil a high potential oral insulin. The company's business model spans the entire drug value chain from pre-clinical discovery to clinical development and through to commercialisation and focused on biopharmaceuticals custom research and clinical research. Biocon is an ISO 9001 ISO 14001:2004 ISO 9001:2000 ISO 15189:2003 and also OHSAS 18001:1999 certified for various levels. Biocon has two subsidiary companies for support namely Syngene International Ltd and Clinigene International Ltd. Biocon has rapidly developed a robust drug pipeline led by monoclonal antibodies and several other molecules at exciting stages in the biopharmaceutical value chain.Biocon Limited was incorporated in the year 1978 as a joint venture between Biocon Biochemicals Limited of Ireland and an Indian entrepreneur Kiran Mazumdar-Shaw. Biocon manufactured and exported enzymes to USA and Europe during the year 1979 as first of its kind. In 1989 Unilever plc acquired the Biocon Biochemicals Limited in Ireland and merges it with its subsidiary Quest International. Also in the same year the company had received US funding for proprietary technologies. After a year in 1990 Biocon had scaled 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 received ISO 9001 certification from RWTUV Germany during the period of 1993. In the year 1994 the company had established the 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 during the year 1996 and also in the same year the company had leveraged its technology platform to enter biopharmaceuticals and statins. Biocon had spearheads initiatives in human healthcare in the year 1997 through a dedicated manufacturing facility. During the year 1998 Unilever inked a deal with ICI to sell its specialty chemicals division of which Quest International is a part. Unilever agreed to sell its shareholding in Biocon to the Indian promoters. Biocon becomes an independent entity in same period. In the year 2000 Biocon had commissioned its first fully automated submerged fermentation plant to produce specialty pharmaceuticals and also in the same year the company had established Clinigene India's first Clinical Research Organisation (CRO) to pursue clinical research and development. During the year 2001 Biocon becomes the first Indian company to be approved by US FDA for the manufacture of lovastatin a cholesterol-lowering molecule. During the same year of 2001 the company's proprietary bioreactor PlaFractor was granted a US 2001 and worldwide patent. Later on in 2002 Clinigene's clinical laboratory of the company received CAP accreditation as the first in India. The Company had developed the human insulin on a Pichia expression system in the year 2003. Biocon created a buzz in the stock market in March of the year 2004 with its hugely successful IPO. Day 1 on the bourses closed 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. During the same year 2004 the Syngene had established new research centre launched INSUGEN the new generation bio-insulin manufactured in Asia's largest human insulin plant.Biocon Limited and Vaccinex Inc collectively announced a broad strategic partnership to discover and co-develop at least four therapeutic antibody products. Biocon had signed a commercial agreement for supply of insulin API to Asia Africa and the Middle East during the period of 2005. During the year 2006 the company inaugurated 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 and also established Biocon Biopharmaceuticals India's largest multi-product Biologics facility at Biocon Park. In the same year 2006 Biocon's Syngene and Innate Pharmaceuticals AB Umea Sweden conclude a cooperation agreement to jointly develop manufacture and market virulence blockers to counteract bacterial diarrhoeal disease and also launched India's first anti-cancer drug BIOMAb EGFR. Abu Dhabi based pharmaceutical company Neopharma had signed an MOU with the company to establish a JV to manufacture and market a range of biopharmaceuticals for the GCC countries (Gulf Cooperation Council) in the year 2007. The Company launched its Nephrology Division and a comprehensive portfolio of renal therapy products. Syngene had entered into a research partnership with Bristol-Myers Squibb and completes the groundbreaking ceremony of new research facility at Biocon Park. During the identical year of 2007 Biocon signed Memorandum of Understanding with Deakin University Australia to establish Deakin Research Institute in Bangalore. The Company divested its enzymes division for USD 115 million to Novozymes. Biocon and Neopharma signed an MOU in July of the year 2007 to establish Neobiocon a joint venture company in Dubai's biotechnology and research park Dubiotech. As at January 2008 Biocon Limited and IATRICa Inc made a strategic partnership to co-develop an exclusive new class of immunoconjugates for targeted immunotherapy of cancers and infectious diseases. In February of the year 2008 the company had acquired 78% stake in German pharmaceutical company AxiCorp GmbH for a consideration of 30 million Euros. As at June 2008 Biocon launched 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. During the year Biocon wass ranked among the top 20 global biotechnology companies and 7th largest biotech employer in the world (Med Ad News). Also during the year 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.In 2009 Biocon launched BASALOG - long lasting basal insulin for Type 1 & Type 2 Diabetics. During the year the company inked partnership with ISB to launch the Biocon Cell for Innovation Management. During the year Biocon announced Strategic Collaboration with Mylan to enter the Global Generic Biologics Market. During the year 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. Also during the year Biocon and HCG group of hospitals joined hands in fight against cervical.In 2010 Biocon and Bayer joined hands to create awareness for self monitoring for diabetics. During the year Biocon acquired the stake of its Cuban partner CIMAB S.A. in their seven year old JV Biocon Biopharmaceuticals Pvt. Ltd. In 2010 Biocon and Optimer Pharmaceuticals announced manufacturing and supply agreement for a novel API first-in-class anti-infective (C. difficile). During the year Biocon and the Center of Molecular Immunology (CIM) based in Havana Cuba strengthened their existing research partnership by joining forces for an integrated antibody program in immunology. During the year Biocon announced a strategic foreign direct investment in Malaysia with the Malaysian Biotechnology Corporation SdnBhd (BiotechCorp).In 2011 Biocon sold 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. In 2011 Biocon announced project commencement for first high-end biopharmaceutical manufacturing and R&D facility in Bio-XCell Malaysia. During the year Biocon launched INSUPen a convenient and affordable reusable insulin delivery device.In 2012 Biocon announced positive results from its Global Phase 3 study with Recombinant Human Insulin. During the year GE Capital announced investment in Syngene Biocon's Research Services Subsidiary. During the year Biocon announced Positive Efficacy Data from Phase 3 clinical study with its Novel Monoclonal Antibody Itolizumab for Psoriasis. Biocon also announced positive results from its Phase 1 Comparative PK-PD Study with Biosimilar Insulin Glargine. During the year Biocon entered into an agreement with Bristol-Myers Squibb for its IN-105 an Oral Insulin drug.In 2013 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. During the year Biocon expanded its partnership with Mylan through Strategic Collaboration for Insulin Products. In 2013 Biocon launched ALZUMAb- a 'First in Class' Novel Biologic Treatment for Psoriasis Patients in India. During the year Biocon partnered with CytoSorbents to Market CytoSorb - A 'First-in-Class' Therapy for Sepsis Management. During the year Biocon and Mylan received Indian Regulatory Approval for Trastuzumab for Treating Breast Cancer. In 2013 Biocon and Quark Pharmaceuticals announced collaboration to Develop Novel siRNA based Therapeutics.In 2014 Biocon introduced CANMAb - Trastuzumab for treating Breast Cancer in India. During the year Silver Leaf Oak (Mauritius) Limited an investment vehicle advised by India Value Fund Advisors 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. During the year Biocon expanded its Strategic Partnership with CytoSorbents to treat SIRS and Cardiac Surgery Patients.In 2015 Biocon commissioned Asia's largest integrated insulin manufacturing facility at the Biotech Park in Johor Malaysia. During the year Biocon received approval in Mexico for Insulin Glargine through its partner PiSA Farmaceutica. During the year Biocon's Research Services subsidiary Syngene International was listed on the bourses after an initial public offer (IPO). In 2015 Biocon inaugurated a World Class devices facility in Bangalore and introduced Basalog One in India.In 2016 Mylan and Biocon announced USFDA submission for proposed Biosimilar Trastuzumab. Mylan and Biocon also announced that regulatory submission for Insulin Glargine and proposed Biosimilar Pegfilgrastim were accepted for review by European Medicines Agency. During the year Biocon launched its Insulin Glargine in Japan. During the year Biocon and Quark announced initiation of Pivotal Phase II/III Study of QPI-1007 in Rare Eye Disease in India. During the year Biocon received its first generic formulation approval in European Union. Also during the year Biocon signed Co-Development & Commercialization Agreement with Lab PiSA for rh-Insulin in USA.In 2017 USFDA accepted Biologics License Application (BLA) for Mylan and Biocon's proposed Biosimilar Pegfilgrastim for review. During the year Biocon started commercial operations at its Malaysia facility with MYR 300 million contract from MoH Malaysia to supply rh-insulin. During the year USFDA accepted Biologics License Application (BLA) for Mylan and Biocon's proposed Biosimilar Trastuzumab.On 18 January 2018 Biocon and Sandoz a Novartis division and a global leader in biosimilars announced a global partnership to develop manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide. Under the terms of the agreement both companies will share responsibility for end-to-end development manufacturing and global regulatory approvals for a number of products and will have a cost and profit share arrangement globally. Worldwide commercialization responsibilities will be divided and each company's strengths will be leveraged within specific geographies. Sandoz will lead commercialization in North America and the EU while Biocon will lead commercialization in Rest of the World.On 29 January 2018 Mylan N.V. one of the world's leading pharmaceutical companies and Biocon announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Semglee insulin glargine a long-acting insulin analog used in the treatment of diabetes mellitus in adults adolescents and children aged 2 years and above. Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and insulin analogs.Mylan and Biocon on 28 March 2018 announced that their co-developed biosimilar insulin glargine Semglee has received marketing authorization approval from the European Commission (EC) following the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency. Semglee 100 units/mL 3 mL prefilled disposable pen for people with diabetes is the first biosimilar from Biocon and Mylan's joint portfolio to be approved in Europe. The EC approval of Semglee applies to all 28 European Union (EU) member states and the European Economic Area (EEA) member states of Norway Iceland and Liechtenstein. Additionally the Therapeutic Goods Administration (TGA) Australia has also approved biosimilar insulin glargine Semglee 100 IU/mL 3 mL prefilled pen for the people with diabetes in Australia.On 11 April 2018 Biocon announced that the company and Mylan have agreed to accelerate introduction of adalimumab biosimilar in Europe through Mylan's in-licensing arrangement with Fujifilm Kyowa Kirin Biologics (FKB). FKB's product is at an advanced stage of review and could potentially obtain approval in Europe in the second half of 2018. Through this arrangement Mylan could commercialize FKB's Adalimumab in EU around market formation. Biocon retains its economic interest in this arrangement vis-a-vis Mylan in line with its existing global collaboration with Mylan for monoclonal antibodies.