Biosimilar Pathway Would Disappear If ACA Repealed, Gottlieb Says

Asked during Senate hearing whether the 351(k) pathway would be repealed along with the rest of the ACA under a pending lawsuit, the outgoing commissioner acknowledged that it would,  but said he hoped Congress would create it again.

US Capitol building at night

The US FDA may be plunged into the middle of a new fight over the future of the Affordable Care Act, as its biosimilar approval pathway is potentially at risk.

Indeed, among the many provisions in the ACA was creation of an abbreviated approval mechanism for biosimilars, which allowed the...

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