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Mass. biotechs leaping into generic drug market

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Boston Articles
January 20, 2012|By Robert Weisman

Biotechnology companies spent years lobbying against allowing generic versions of their expensive cutting-edge medicines, warning that copying complicated drugs made from living cells could put patients at risk and undermine innovators.

But that was then.

Bowing to the inevitability of low-cost competition as federal officials push to contain health care spending, biotechs are now scrambling to secure a piece of the discount market for themselves. And Massachusetts, known for its influential cluster of biotechnology companies, is at the center of the action.

Over the past month, three formidable players - Momenta Pharmaceuticals Inc. of Cambridge, Biogen Idec Inc. of Weston, and Amgen Inc. of Thousand Oaks, Calif., which operates a research lab in Cambridge - have started separate ventures to develop, make, and market generic biotech drugs, known in the industry as “biosimilars.’’

Their efforts raise the prospect that cheaper generics, long seen as a threat to one of the highest-profile industries in Massachusetts, could instead spur new growth in the sector when the first biosimilars are made available in the next several years.

“Boston is already a hub for the biotechnology business, and now there’s a lot of potential for Boston companies to get into’’ the biotech generics market, said Momenta chief executive Craig A. Wheeler. Last month, the company formed a generics collaboration with medical products giant Baxter International of Deerfield, Ill.

Biotech drugs are made from live organisms, in contrast with traditional medicines, which are derived from chemicals. While generic versions of conventional drugs have taken an increasingly larger slice of the pharmaceutical market over the past 25 years - outstripping sales of brand-name medications - biosimilars aren’t yet available in the United States, in part because the manufacturing process is so complex and expensive. But under a 2010 law, the US Food and Drug Administration is developing a process by which they could be approved, and a set of regulations is expected to be released this year.

“Everyone was resisting it tooth and nail until legislation was passed, but now the starting gun has been fired,’’ Wheeler said. “I’m personally not of the view that this is going to undermine the industry. I think it’s going to spark innovation.’’

Biosimilars already are sold in some European countries, but the market is relatively small. Still, the IMS Institute for Healthcare Informatics, a Norwalk, Conn., research firm, has projected global spending on generic alternatives to biotech drugs will increase from $311 million in 2010 to between $2 billion and $2.5 billion in 2015.

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