Gottlieb unveils US biosimilars action plan
A much-anticipated biosimilars action plan (BAP) unveiled by US Food and Drug Administration (FDA) commissioner Scott Gottlieb has been warmly received by industry. Commending the release of the plan, the US Association for Accessible Medicines (AAM) called it “another key plank in the FDA’s platform to ensure robust and timely competition from generic and biosimilar medicines”.
You may also be interested in...
A draft guidance document opened for comment by the FDA offers additional Q&As on issues around biosimilar applications and interchangeability.
The past decade has been transformative for the global biosimilars industry as regulators, developers, physicians, patients and payers from all over the world have grappled with complex, and often market-shaping, issues.
More should be done by the FDA to counter misinformation perpetuated by originators over biosimilars, the AAM and its Biosimilars Council have urged in comments attached to a citizen petition lodged by Pfizer.