- Collaboration aims to help patients worldwide gain access to a range of high-quality, affordable immunology and oncology biologics
- Partnership will be an important part of Biocon and Sandoz´ strategy to address the next wave of biosimilars opportunities globally
- Collaboration will leverage combined strengths of development, manufacturing and commercialization of biosimilars
- Partnership provides foundation for expansion of portfolio
Bengaluru, India, January 18, 2018
Biocon Ltd (BSE code: 532523, NSE: BIOCON), Asia's premier biopharmaceuticals company, and Sandoz, a Novartis division and a global leader in biosimilars, today 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.***
Biocon Chairperson & Managing Director Kiran Mazumdar-Shaw said: “We are pleased to announce our collaboration with Sandoz for developing a set of next generation biosimilar products. This synergistic partnership will enable us to scale up our capabilities for an 'end to end' play in the global biosimilars space. We remain committed to pursue our mission of developing biopharmaceuticals that have the potential to benefit a billion patients across the globe.”
Dr. Arun Chandavarkar, CEO & Joint MD, Biocon, added: “Biocon has worked at the leading edge of science and has demonstrated its capabilities in developing high quality biosimilars. Our credibility has been further endorsed by the recent USFDA approval of our Biosimilar Trastuzumab, which is also the first in the US. Our collaboration with Sandoz will bolster our existing global biosimilars portfolio comprising biosimilar antibodies & insulin analogs and will enable us to address the next wave of global biosimilars opportunities.”
As an innovation-led biopharmaceutical company, Biocon has successfully developed and taken a range of novel biologics, biosimilar antibodies, rh-insulin and insulin analogs from 'lab to market'. The collaboration with Sandoz builds upon Biocon's successful progress in its existing global biosimilars program. The most recent USFDA approval of the first biosimilar of Trastuzumab, marks an important milestone for Biocon as it is also the first biosimilar to be approved in the US for any Company from India. An early mover in the biosimilars space, Biocon has successfully launched its insulin glargine in Japan, Trastuzumab & Bevacizumab biosimilars in India and rh- Insulin, Insulin Glargine and biosimilar Trastuzumab in few emerging markets.
Sandoz is committed to increasing patient access to high-quality biosimilars and has five biosimilars currently marketed worldwide, as well as a rich global pipeline. Sandoz is well placed to strengthen its position in the biosimilars space based on its experience and capabilities in development, manufacturing and commercialization. As a division of Novartis, the first global healthcare company to establish a leading position in both innovative and off-patent medicines, Sandoz benefits strongly from this unique blend of experience and expertise in many different market environments.
Biocon's collaboration with Sandoz addresses some of the biosimilar opportunities beyond the near term opportunities being addressed by Biocon's existing successful global partnership with Mylan. This new partnership is a significant milestone in Biocon's journey of developing advanced therapies that have the potential to benefit billions of patients.
**US and Canada
**including European Free Trade Association (EFTA) and Balkan states
***including India, Russia and Commonwealth of Independent States (CIS)
Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is India's largest and fully-integrated, innovation-led biopharmaceutical company. As an emerging global biopharmaceutical enterprise serving customers in over 120 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), BIOMAb-EGFR™ (Nimotuzumab), CANMAb™ (Trastuzumab), Evertor® (Everolimus) 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.
Forward-Looking Statements: Biocon
This press release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release.