The U.S. Food and Drug Administration, FDA, has published its Biosimilars Action Plan in July 2018. To further improve coordination and support of all activities related to biosimilar and interchangeable product development and approval, FDA is in the process of transferring the TBBS (Therapeutic Biologics and Biosimilars Staff) to the Office of Therapeutic Biologics and Biosimilars (OTBB). The transfer to OTBB will:
Therefore, FDA is prioritizing the development of the following guidances:
Furthermore, the FDA is developing a proposed rule on the interpretation of the definition of "biological product" which would provide additional clarity and predictability for sponsors regarding the appropriate review pathway for such products. To improve regulatory clarity, the FDA is evaluating its regulations regarding the submission and review of BLAs (Biologics License Applications) to ensure that they account for current practices and authorities.
Additionally, the FDA recently published its final guidance on Labeling for Biosimilar Products.