Biosimilars For US Market May Be Able To Rely On EU-Licensed Reference Products

Commissioner Scott Gottlieb says move could allow biosimilar sponsors to avoid anti-competitive efforts by brand sponsors in US.

LI-2 Protein_564977620_1200.jpg

The US FDA's upcoming plans to stimulate and streamline biosimilar development could include the ability for sponsors to use European-approved reference products to gain US approval.

Commissioner Scott Gottlieb said the issue is one of the items that could appear in the biosimilar innovation plan, which...

More from Biosimilars

More from Biosimilars & Generics