India's Biocon has partnered with US-based Mylan to sell Indian-made biogenerics globally. Bangalore-based Biocon sees the collaboration with Mylan, the world's third-largest generics producer, as a strategic opportunity to take generic versions of insulin, monoclonal antibodies and other protein therapeutics in its pipeline, to regulated markets such as the US and Europe. The new alliance combines Biocon's cost-efficient biologics manufacturing with the Pittsburgh-based company's global commercial reach and regulatory expertise. The two companies will share development, capital and certain other costs of bringing the products into global markets, although financial details have not been disclosed. Monoclonal antibodies will be the cornerstone of this pact, Kiran Mazumdar-Shaw, Biocon's chairman, told shareholders at a recent meeting. Hareesh Parandhman, until recently at Ahmedabad-based Intas, agrees that the business strategy makes sense if Mylan absorbs the development and regulatory expenses, as Europe and the US do not allow generics without clinical trials in their countries. “I cannot imagine Biocon or any Indian biogenerics company going to Europe or the United States on its own,” he says. But Krishna Ella, CEO of Hyderabad-based Bharat Biotech points out that, “Europe and the US will not be [an] easy walkover considering that the patent issue is more complicated in the case of biologicals, where product as well as the processes used are covered by patent.”
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