FDA to release biosimilars plan July 18

FDA’s Biosimilars Action Plan is likely to include elements the agency has disclosed in recent months that are intended to make reviews of biosimilars more predictable, reduce barriers to gaining approval of interchangeable biologics, and remove barriers to biosimilar competition.

The agency has not provided details of the plan, which is slated for release on July 18, but FDA Commissioner Scott Gottlieb tweeted on July 8 that the plan will include enhanced education for healthcare providers and patients, “reducing gaming that may delay market competition, strengthening [international] regulatory partnerships and providing clarity for product developers via guidance and meetings.”...