Stakeholders Question Biosimilar Standards For 'Transition' Biologics

While FDA has released a biologics naming guide proposing the addition of nonmeaningful suffixes to biosimilars and their reference product's nonproprietary names, the agency has not offered guidance on naming or other considerations for biologics that were approved under the Food, Drug and Cosmetic Act (FDCA) and will be transitioning to biological licenses under the Public Health Service Act in March 2020. Industry members are questioning what standards biologics will have to meet to be considered biosimilar and interchangeable. "We...