Tag Archive | "European Free Trade Association"

A U.S. Generics Shop Looks to India for Biotech

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The details are still a bit fuzzy, but it’s clear that sooner or later generic biotech drugs are coming to the U.S. Big Pharma knows this, and has been angling to get into the game. U.S. generics makers know it too — as evidenced by today’s deal between Mylan, a generics shop based in Pennsylania, and Biocon, an Indian biotech company.

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Making biotech drugs — even generic ones, known in the business as follow-on biologics — is way more complicated than churning out traditional medicines. So it makes sense that Mylan, which is an expert in making generic copies of traditional drugs, would partner with an outside firm that focuses on biotech. By the same token, cracking the market for generic biotechs in the developed world might also be tricky — so it makes sense that an Indian firm might want a U.S. partner.

The companies didn’t disclose specific financial terms in their statement, but here’s the gist:

Mylan and Biocon will share development, capital and certain other costs to bring products to market. Mylan will have exclusive commercialization rights in the U.S., 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.

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They’ll have plenty of competition from big pharma. Merck is creating its own generic biotech arm, using the know-how of a biotech company it acquired a few years back. Novartis, an old hand in traditional generics, is already getting into follow-on biologics. And AstraZeneca’s CEO has mulled making the leap as well.

Source: The Wall Street Journal

Popularity: 2% [?]

Mylan and Biocon Join Forces to Develop Biosimilars

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Mylan is allying with Biocon for the development, manufacturing, supply, and commercialization of multiple generic biologic compounds for the global marketplace. The companies will share development and certain other costs related to bringing the products to market.

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Mylan will have exclusive commercialization rights in the U.S., Canada, Japan, Australia, New Zealand, the EU, and European Free Trade Association countries (Iceland, Liechtenstein, Norway, and Switzerland) through a profit-sharing arrangement. Mylan will have co-exclusive commercialization rights with Biocon in all other markets around the world.

“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,” notes Mylan’s chairman and CEO, Robert J. Coury.

“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.”

Source: GEN News

Popularity: 2% [?]

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