Biocon, Mylan tie up for generic biologic drugs

Biocon Ltd, the country's premier biotechnology firm, has signed a definitive agreement with the world's third largest biopharma company, Mylan Inc, to develop, manufacture and supply generic biologic drugs globally.

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 commercialisation 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 also have co-exclusive commercialisation rights with Biocon in all other markets around the world.

Bio-generics in the emerging markets are expected to grow 20 per cent in the next five years from the current $1.5 billion. Biocon can utilise Mylan's regulatory and commercialisation capabilities in the US and Europe for a cost effective model to tap the opportunity for generic biologics recently supported by the Obama administration.

"Monoclonal antibodies are emerging as the most dominant class in biologics," said Kiran Mazumdar-Shaw, Biocon chairman and managing director. "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."

The generics segment is currently based on chemically synthesised drugs, and is looking for a fundamental change. The pressure to lower health care costs is galvanising governmental efforts globally to facilitate the entry of generic bio-tech or protein derived drugs.

Mylan's chairman and CEO, Robert J Coury said, "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. 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 organisation 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."