Home » Experts: FDA Guidance on Biosimilars Could Be Years Away
Experts: FDA Guidance on Biosimilars Could Be Years Away
As drugmakers continue to wait for the FDA to develop an approval pathway for biosimilars, industry experts are beginning to think that any guidance from the agency could be years away. “I expected [the FDA] to be somewhat further along on the curve when the law was passed, [but] that has not been the case,” Steve Grossman, president of the consulting firm Health Policy Solutions Group, said at a biosimilars conference sponsored by the Center for Business Intelligence in Washington. “Under the best of circumstances this is a two- to five-year process.”
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