FDA Weighs Offering Tentative Biosimilar Approvals, Grapples With Exclusivity

FDA is still grappling with the level of evidence necessary to demonstrate that a biologic has been changed enough to warrant a new period of exclusivity as the agency begins to interpret exclusivity provisions in setting up the biosimilar pathway, an agency official said. FDA is also considering the possibility of granting tentative approvals to biosimilars as applications could be submitted years before biologic exclusivity runs out. Recently released FDA guidance outlines how biologic sponsors could help FDA determine the...