Merck makes a play for generic biologics market

Merck makes a play for generic biologics market
Merck makes a play for generic biologics market
Merck is betting on Democratic plans to speed development of generic biologics, making a play for the market with a new unit tasked with designing the products and promising, in the words of president and CEO Dick Clark, a “new Merck built for the new era that our industry has entered.”

The company said in its annual business briefing Tuesday that it is seeking to diversify its portfolio with the launch of a new division, Merck BioVentures, tasked with developing follow-on and novel biologics. Over the next seven years, Merck plans to invest $1.5 billion in the venture, which has its origins the company's 2006 acquisition of GlycoFi. Merck aims to have at least five follow-on biologic candidates in late-stage development by 2012.

“We believe we can become a leading provider of high-quality, competitively priced follow-on biologics,” said Clark.

With many pricey blockbuster biologics set to expire over the next decade, the market has great potential, though Washington has yet to determine how FDA should regulate follow-ons.    

Rep. Henry Waxman (D-CA), the incoming chairman of the House Committee on Energy and Commerce, has vowed to make passing legislation allowing development of the products, sometimes called “biosimilars,” a priority. Past attempts at establishing a regulatory pathway for such products have gotten bogged down in questions over what sort of approval process is necessary, given that the treatments aren't exact copies of those they claim to emulate. Some say they should be treated as entirely new drugs and subjected to the standard approvals process, while others want fast-track status.

Merck is also looking to expand its business in emerging markets such as China and India, much as rivals including Pfizer and AstraZeneca have vowed to do, setting a goal of $2 billion in emerging market sales by 2010.

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