FDA Finalizes Biosimilar Naming Convention, Punts On Interchangeability

FDA will not change course on a controversial biologic naming convention it outlined in 2015, the agency announced in a final guidance released Friday (Jan. 12), but has yet to chart its course on the hot-button topic of how to name interchangeable biosimilars. A biologic expert says the agency's ultimate decision on interchangeability naming could have a lasting impact on the industry. The brand-name and generic trade groups have been at odds over the issue of naming, with brand-name friendly...