FDA announces new steps on naming of biological medicines

FDA Commissioner Scott Gottlieb, MD, announced Thursday that the agency no longer plans to change the proper names of biological products that have already been licensed or approved under the Public Health Service Act without an FDA-designated suffix in their proper names.

FDA Commissioner Scott Gottlieb, MD, announced Thursday that the agency no longer plans to change the proper names of biological products that have already been licensed or approved under the Public Health Service Act without an FDA-designated suffix in their proper names. The updated draft guidance from FDA also noted the agency does not plan to apply the naming convention to the proper names of transition biological products. Additionally, for interchangeable biosimilars going forward, FDA will designate a proper name that is a combination of the core name and a distinguishing suffix that has no meaning and uses four lowercase letters. "This framework will help secure pharmacovigilance so that the FDA can effectively monitor all biological products in the post market—originators and biosimilars—and promote patient safety," Gottlieb said. "To aid in adverse event report tracking, originator, biosimilar and interchangeable products will have nonproprietary names that are distinct from each other. Additionally, under this updated policy, any product that is first licensed as a biosimilar and later determined to be interchangeable will keep its nonproprietary name after receiving a determination of interchangeability."