Biocon Limited is Indias largest and fully-integrated, innovation-led biopharmaceutical company. The Company is engaged in the manufacture of biotechnology products and research services. 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. Biocons 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 Biocons 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, Indias 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 companys proprietary bioreactor, PlaFractor was granted a US 2001 and worldwide patent. Later on, in 2002, Clinigenes 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 Asias 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, Indias 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, Indias largest multi-product Biologics facility at Biocon Park. In the same year 2006, Biocons 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 Indias 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 Dubais 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 Biocons 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, Biocons 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, Biocons 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 Asias 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, Biocons 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 Biocons 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 Biocons 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 companys 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 worlds leading pharmaceutical companies, and Biocon announced that the European Medicines Agencys 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 Mylans 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 Mylans in-licensing arrangement with Fujifilm Kyowa Kirin Biologics (FKB). FKBs 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 FKBs 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.During FY19, Companys first Generic Formulations plant, commissioned in 2017, received U.S. FDA approval. It commercialized Ogivrir* (Trastuzumab) in Europe. It signed agreement with GSK to advance drug discovery in multiple therapy areas. It signed agreement with Biotechnology Industry Research Assistance Council (BIRAC) to set up a Centre for Advanced Protein Studies.In FY21, Company launched Tacrolimus capsules, Biocons first immunosuppressant formulation in the U.S., for the benefit of organ transplant patients. It also entered new partnerships to expand commercial footprint to Singapore, Thailand and Brazil. It received U.S. FDA approval for Everolimus (gAfinitor), an immunosuppressant formulation to prevent rejection of organ transplants, and treat renal cell cancer and other tumors. It entered into a partnership with Libbs Farmaceutica, marking the entry of Biocons Generic Formulations into Latin America, starting with Brazil. It partnered with DKSH to expand access to Biocons Generic Formulations portfolio in key South East Asian markets of Singapore and Thailand. It continued to build Generic Formulations portfolio through new regulatory filings in the U.S., EU and Most of World markets. It received a GMP compliance certificate from MHRA, UK, for Generic Formulations manufacturing facility at Biocon Park in Bengaluru. It extended till 2030, a long-standing partnership with Bristol Myers Squibb (BMS) for drug discovery research. It entered a 5-year pact with 3DC, the drug discovery and development unit of Deerfield Management Co, to advance therapeutic discovery projects. It helped partner Albireo Pharma advance their compound to regulatory filings in U.S. and Europe, putting it on track to be the first approved drug for treating specific genetic liver diseases, primarily in children. It continued to support clients on drug research projects for leukemia, Parkinsons disease, inflammatory disorders, fibrotic disorders and orphan diseases. It expanded research facility in Hyderabad by adding capacity for an additional 90 scientists. It commissioned a new microbial manufacturing facility to reduce dependency on external service providers. It commercialized third biosimilar, Insulin Glargine, in the U.S. and obtained regulatory approvals for key biosimilars Bevacizumab and Insulin Aspart in the European Union. Its biosimilars benefited 3.1 million patients during the year. In association with partner, Viatris, the Company commercialized bGlargine (Semglee) in the U.S. and Fulphila in Australia and Canada. Its product pipeline got a boost with approvals from European Commission for biosimilar Bevacizumab and biosimilar Insulin Aspart, co-developed with Viatris. It commenced a multiple ascending doses (MAD) study for Type 1 DM in Germany in FY20, in partnership with the U.S.-based Juvenile Diabetes Research Foundation (JDRF) for Insulin Tregopil. Itolizumab, was granted Restricted Emergency Use approval in July 2020 to treat Cytokine Release Syndrome (CRS) in moderate to severe Acute Respiratory Distress Syndrome (ARDS) patients in India. The drug was subsequently made available in the domestic market, having benefited over 27,000 patients as of May 2021. BCA101, the lead program for Boston-based Bicara Therapeutics, a first-inclass EGFR / TGF-trap bifunctional antibody, entered a Phase 1/2 study at leading U.S. and Canadian cancer centers in July 2020. It ceded control over the Board and operations of Bicara Therapeutics, which housed our immuno-oncology program focused on developing novel bifunctional fusion antibodies. It received approval for Bevacizumab from the National Pharmaceutical Regulatory Agency (NPRA) in Malaysia. In July 2021, the European Medicines Agencys Committee for Orphan Medicinal Products granted an orphan medical product designation to Itolizumab for the treatment of both acute and chronic GVHD. This was a milestone for the Company as it intend to develop this drug for patients in Europe upon regulatory approval. In FY22, the Company launched five products in the U.S. It strengthened its U.S. formulations portfolio with the launch of Labetalol Hydrochloride tablets and Esomeprazole Magnesium Delayed-Release capsules. It received approval from the U.S. FDA for ANDA for Mycophenolic Acid, which is indicated for the prophylaxis of organ rejection in adult patients receiving kidney transplants. It commenced first Most of the World (MoW) market supply of Tacrolimus capsules to Mexico, and received its first approval for Tacrolimus in Singapore, and for Rosuvastatin and Tacrolimus in the UAE. It also obtained Marketing Authorization for Everolimus tablets in the Netherlands and Spain. It received a Certificate of Good Distribution Practice (GDP) Compliance of a Wholesale Distributor from the Maltese authorities for the import and marketing of drug products in the European Union. More recently, it received a Compliant rating from Health Canada for API manufacturing facility in Bengaluru. It signed a strategic alliance with Serum Institute Life Sciences, marking an asset-light and accelerated entry into vaccines. It advanced two unpartnered antibody programs, bUstekinumab and bDenosumab, to the clinical phase. It executed a Day 1 U.S. launch of Everolimus 10 mg tablet, a generic formulation for treating certain cancers and tumors. In FY22, it completed 34 product filings globally for APIs, including five in the U.S., and 28 filings for formulations, out of which 11 were in the U.S. It signed a partnership deal with Tabuk Pharmaceutical Manufacturing Company, a fully-owned subsidiary of Astra Industrial Group, to commercialize select specialty generic medicines in the Middle East region, expanding the global presence of the Generic Formulations business. It received several product approvals in Most of the World (MoW) markets in FY22. During the year 2022, Company went through various regulatory audits at some of its key sites, with successful outcomes. At the Oral Solid Dosage (OSD) facility in Bengaluru, the U.S. FDA conducted a Remote Interactive Evaluation (RIE) in September 2021, which was a pre-approval review for ANDAs filed earlier. The facility also secured a certificate of Good Manufacturing Practice (GMP) from the Medicines and Healthcare Products Regulatory Agency (MHRA), U.K. based on a remote inspection. The certificate included manufacturing and packaging of tablets and capsules in the nonpotent and potent blocks of the facility. Furthermore, the Maltese authorities conducted a Wholesale Dealer License (WDL) and Manufacturing/ Importation Authorization (MIA) inspection, and thereafter, granted Company a Certificate of Good Distribution Practice (GDP) of a Wholesale Distributor, that enabled to import and market products in the European Union. Towards the end of the fiscal, Health Canada also conducted a remote inspection of API manufacturing unit in Bengaluru and rated it as Compliant It commenced clinical trials for two of its unpartnered assets, bUstekinumab for inflammatory conditions and bDenosumab to treat osteoporosis and cancer. It received favorable rulings from the U.S. Federal Circuit related to patents covering the originators device and formulation for administering bGlargine.During 2022-23, the Company commissioned its greenfield, fermentation-based immunosuppressant API manufacturing facility in Visakhapatnam, Andhra Pradesh and peptides API manufacturing facility in Bengaluru. It began work on expanding synthetic and non-immunosuppressant fermentation capacities in addition to a new injectable facility. Two important APIs, Sitagliptin and Vildagliptin were launched in the European Union. bBevacizumab was launched in 12 countries; a new insulin analog from bAspart portfolio was launched in Canada and Malaysia. In FY23, the Company launched five generic formulation products. In the UK, it launched Posaconazole and in the European Union, Rosuvastatin.
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