Biocon has entered into a definitive agreement with Mylan Inc, for an exclusive collaboration on the development, manufacturing, supply and commercialization of multiple, high value generic biologic compounds for the global marketplace.
Through this partnership, Mylan and Biocon bring together highly complementary capabilities that will significantly advance their efforts to secure a leading position in the emerging generic biologics industry.
Biocon is well positioned to capitalize on new opportunities through its early investments in research, development and manufacturing of high quality protein therapeutics, including both novel biologics and bio-generics. Combining this with Mylan's regulatory and commercialization capabilities in US and Europe creates a cost effective model to address a large, emerging opportunity for generic biologics recently supported by the Obama administration.
Kiran Mazumdar-Shaw, chairman and managing director, said, "Biocon is extremely pleased to have found a partner as strong as Mylan to accelerate our work in generic biologics and take it to the next level around the world, especially in regulated markets. I am confident that our shared vision for the sector, complementary skills, mutual respect and work ethic will make this collaboration a remarkable success while bringing additional value to Biocon and its shareholders. Monoclonal antibodies are emerging as the most dominant class in biologics. Through this partnership we hope to deliver high quality, affordable bio-generic antibodies and biologics, thereby addressing a critical need to lower spiraling healthcare costs in both the developed and emerging economies."
Mylan's chairman and CEO, Robert J Coury commented "I am extremely excited to be able to announce what I consider to be one of the more comprehensive and high quality biologics initiatives reported within the industry to date. This unique collaboration combines Biocon's scientific expertise; excellent product development track record; appreciation of complex regulatory requirements; and state-of-the-art, cost-efficient and scalable biologics manufacturing with Mylan's one-of-a-kind global commercial footprint and our regulatory expertise around the world. Biocon also has a unique corporate culture that is very similar to Mylan's."
"All of these attributes will provide a critical synergy and create a strong and effective long-term partnership. Generic biologics, especially monoclonal antibodies, are expected to become the next great bolus of growth in the generic pharmaceutical industry, and through this alliance, Mylan and Biocon have covered all four corners of what any organization would want or need to have secured to offer a highly competitive and distinct generic biologics product portfolio with tremendous growth potential for the coming decade," Coury added,
The generics segment in the pharmaceutical industry, which is currently based almost entirely on chemically synthesized drugs, is poised for a changing paradigm. The pressure to lower health care costs is galvanizing governmental efforts globally to facilitate the entry of generic bio-tech or protein derived drugs.
An estimated $25 billion worth of biologics will have lost patent protection by 2016, creating a significant market opportunity for protein therapeutics like insulin and its analogs, erythropoietin, human growth hormone, monoclonal antibodies and many others.
The complexity and costs involved in developing generic biologics are expected to see only a few players being able to gain entry into the highly regulated markets of Europe and USA. Bio-generics in the emerging markets are expected to grow from the current estimate of $1.5 billion at a projected rate of over 20 per cent per annum over the next five years.
As part of this collaboration, Mylan and Biocon will share development, capital and certain other costs to bring products to market. Mylan will have exclusive commercialization rights in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries through a profit sharing arrangement with Biocon. Mylan will have co-exclusive commercialization rights with Biocon in all other markets around the world. All other financial terms and product details remain confidential.