Clinical efficacy studies should not be the default for biosimilars development, FDA says
As the FDA and other regulators look to streamline the development of new biosimilars further, the US agency is looking to instill in its foreign counterparts that clinical efficacy studies (CES) should not be mandatory for all new biosimilars to come to market.
A recent workshop for FDA and industry, in addition to another closed-door meeting of about 300 regulators, revealed a “little bit surprising” conclusion that the majority of drug regulators think clinical efficacy studies should be a default requirement for all new biosimilars, Sarah Yim, director of FDA’s Office of Therapeutic Biologics and Biosimilars, said at the generic drug industry group’s GRx+Biosims conference in Bethesda, MD, yesterday.
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