FDA Unveils Action Plan to Boost Biosimilars

FDA Commissioner Scott Gottlieb announced the release of a new action plan for biosimilars and said it would help prime the “anemic” biosimilar market.

Although 11 biosimilars have been approved, only three are currently on the market, Gottlieb noted. The biosimilar action plan adapts the agency’s plan to improve competition and promote innovation in the generics market.

“The ability for these products to penetrate clinical practice, and gain acceptance, is still not firm,” Gottlieb said, adding that “ the policy and regulatory decisions that we make today are going to have a lot to do with whether we realize the promise for this new category of products.”