Biocon | Bangalore

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About Biocon Company

About Us

Biocon is Asia's premier biopharmaceutical company that is driven by the vision to make a difference to global healthcare through improved access to high quality, life-saving biotherapeutics by making them affordable for patients across the world.

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.

Global Scale
To fulfil our mission of making a difference to global healthcare we have made sizable capital intensive investments in research and manufacturing infrastructure to deliver economies of scale. Over the last decade, Biocon has built India’s largest bio-manufacturing facilities in Bengaluru and Asia’s largest insulins manufacturing complex in Malaysia. We have also invested in creating one of the largest fermentation based bulk drug capacities for Statins and Immunosuppressants globally. These investments have and will enable us to have a significant global footprint to serve patient needs.

Peptide & Orlistat

Strategic Capabilities
We have created a highly cross-functional matrix focused on products, processes and people to reliably and consistently develop and deliver differentiated products. We have consistently been among the pharma companies in India with the highest investments in research and development. We have leveraged India’s value advantage of unmatched scientific talent and cost-competitive manufacturing to deliver scale, speed and quality. Over time, we have emerged as a highly innovative biopharmaceuticals enterprise that has benefited millions of patients in over 120 countries.

Commitment to Quality
We have established robust regulatory and quality systems to develop and deliver complex therapeutics. Our state-of-the-art manufacturing facilities are designed to conform to the most stringent cGMP guidelines, comply with international regulatory standards and meet client requirements worldwide. We are ever vigilant on quality and compliance through continuous improvement and regularly evaluate our quality systems and manufacturing operations in order to be on par with global best practices.

Biocon’s business is organized into the following reporting segments:
a) Small Molecules API & Generic Formulations
b) Biologics - Biosimilars (Insulins, MAbs & other Biologics) & Novel Biologics
c) Branded Formulations (currently India & UAE)
d) Research Services (Syngene)

Small Molecules: APIs and Generic Formulations
Biocon has focused on its core biotech capabilities in selecting its differentiated API portfolio largely comprising fermentation-derived molecules such as statins, orlistat, immunosuppresants, and other speciality molecules. These are sold to third party customers who in turn formulate and sell the finished dosages in global markets including the U.S., Europe and large emerging markets. Over the years, we have emerged as the world’s largest statins manufacturer, with our drug substance being used to produce ‘one in every three’ statin pills globally, as well as, a leading player in complex immunosuppressants.

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)
As one of the earliest players in the realm of biologics in India, Biocon has created a rich pipeline of novel and biosimilar assets aimed at addressing local as well as global unmet medical needs associated with non-communicable diseases.


Status of Biocon’s Global Biosimilars Portfolio

Click here to enlarge

Biosimilars
Biocon has one of the largest global biosimilars portfolios, spanning recombinant human Insulin (rh-Insulin), insulin analogs, monoclonal antibodies and other biologics for diabetes, oncology and immunology. We have successfully commercialized several of our biosimilars in various markets across the globe.

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 India’s largest bio-manufacturing facilities in Bengaluru and Asia’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

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Novel Biologics
Apart from biosimilars, our biologics strategy has had a keen focus on developing a pipeline of innovative drugs. Our existing novels portfolio has diverse assets acquired through early stage partnerships. These include monoclonal antibodies against novel targets like CD6, against established targets like CD20 and EGFR, and a pipeline of bispecific fusion antibodies that exploit the recent understanding of the role of checkpoint inhibitors. We are working to clinically validate an orally delivered insulin analog, Insulin Tregopil, which is among the most advanced programs in the global oral insulin space and has the potential to transform diabetes management.

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.

Branded Formulations 
Biocon's Branded Formulations business focuses on regional markets and is currently operational in India and the UAE. This business has focused on specialty brands in critical therapies and enabled Biocon to emerge as a biologics-led healthcare company offering affordable and differentiated medicines of world-class quality to thousands of patients in India and UAE.

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.

Research Services
Our listed subsidiary, Syngene International Limited, is India’s largest Contract Research Organization (CRO). Syngene started as India’s first CRO and has over the years built a reputation as an end-to-end drug discovery and development services provider for novel molecular entities to the global life sciences sector. It provides integrated discovery, development and manufacturing services for novel molecules across multiple platforms including small molecules, large molecules, Antibody-Drug Conjugates and Oligonucleotides. Syngene brings together a state-of-the-art infrastructure spread across 1.3 mn sq ft and a pool of over 3,500 scientists, to help R&D focused organizations achieve better R&D efficiency and reduce development time.

Reputed Biotech Employer
We have built an employee-friendly environment for our gender-diverse workforce that is comparable to the best in the world. The Science Careers Top 20 Pharma & Biotech Employers Survey 2017 rankings placed us at No.9. We have held on to our position amongst the Top 20 global employers since 2012, the only company from Asia to feature in this prestigious list consistently.

Conscientious Corporate Citizen
At Biocon, Corporate Social Responsibility (CSR) is not about philanthropy, but about creating an ecosystem to empower the stakeholders. We believe that access to good education, healthcare services and civic infrastructure form the three pillars of an empowering ecosystem. We work to address the gender disparity gap in education, healthcare and employment. We have also launched several initiatives to preserve India’s rich heritage in art & culture.

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 Foundation
Driven by the principle of making an enduring impact, Biocon Foundation partners the society to promote social and economic inclusion. Biocon has been making significant investments over more than a decade in enhancing access to quality healthcare, education and improved civic infrastructure through the Foundation. Combined with field initiatives, the Foundation’s programs have created the momentum to lift up the marginalized sections of the society. In doing so, it has built a strong reputation for the quality of its programs, mostly implemented by partnering government agencies and like-minded organizations.

Biocon Academy
To create a globally competitive biotech ecosystem in India and make the country’s youth employable, we have set up the Biocon Academy, an advanced centre of biosciences learning. Biocon Academy leverages the rich industry experience of Biocon and subject matter expertise of its education partners to deliver industry-oriented training programs to biotech students. The programs offered by the Academy aim offer advanced learning and industrial proficiency through job-skills development essential to build a promising career in the biotech industry.

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.

Vision

To enhance global healthcare through innovative and affordable biopharmaceuticals for patients, partners and healthcare systems across the globe

Mission

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
clinical research

– Customer relationship through outstanding products
and services

– Human resource development through training,
mentoring and empowering

– Management of research and business partnerships


Values

– Integrity and Ethical Behaviour

– Performance driven work culture

– Value Creation through Innovation & Differentiation

– Quality through Compliance & Best Practices

– Collaboration, Team Work & Mutual Respect

History

Quality

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


1979

Biocon is the first Indian company to manufacture and export enzymes to USA and Europe


1989

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


1990

Biocon scales up its in-house research programme, based on a proprietary solid substrate fermentation technology, from pilot to plant level


1993

Biocon's R&D and manufacturing facilities receive ISO 9001 certification from RWTUV, Germany


1994

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


1996

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


1997

Biocon spearheads initiatives in human healthcare through a dedicated manufacturing facility


1998

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


2000

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


2001

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


2002

Clinigene's clinical laboratory is the first in India to receive CAP accreditation


2003

Biocon is the first company worldwide to develop human insulin on a Pichia expression system


2004

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.

 

2005 

Biocon signs a commercial agreement for supply of insulin API to Asia, Africa and the Middle East.


2006 

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®.


2007 

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 presents the results of Phase 1 studies on its oral insulin product, IN-105 at the European Association for Study of Diabetes (EASD) meeting held at Amsterdam.


2008 

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.


2009 

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


2010

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)


2011

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


2012

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


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

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


2014

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


2015


Biocon commissions Asia’s largest integrated insulins manufacturing facility at the Biotech Park in Johor, Malaysia

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

2016

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

2017

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

2018

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. 

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