Analysis: Regulatory pathway for biosimilars is still unclear

11/2/2010 | Reuters

Although FDA officials have started discussing the creation of a regulatory pathway for approving biosimilars, the agency has not set a deadline for the implementation of such a system, and it could take at least five years for such drugs to reach the market, experts said. "People will be frustrated. It's not going to be a clear pathway for everything," said Ian Spatz, a policy consultant in Washington, D.C., and a former executive at Merck & Co.

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