Biocon Ltd, 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)