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JULY 20, 2018

FDA’s Dr. Gottlieb Chastises Big Pharma for Biosimilar Entry Delays

By Deanna DePeau

The FDA released its Biosimilar Action Plan (BAP), aimed at streamlining the approval and market entry of biosimilars.

“[The] FDA is taking new steps to promote the development of, and competition from, safe and effective biosimilars drugs. These lower cost alternatives can promote access to high-quality, necessary medicines,” tweeted FDA Commissioner Scott Gottlieb, MD, in promotion of the new plan.