FDA issues guidances on biosimilar development

Continuing his pursuit of faster drug approvals, US Food and Drug Administration Commissioner Scott Gottlieb announced in a statement that the FDA has released two guidance documents to facilitate implementation of the “deemed to be a license” provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), as well as a proposed rule that provides FDA’s interpretation of the terms “protein” and “chemically synthesized polypeptide” in the statutory definition of “biological product.”

In addition, Commissioner Gottlieb announced that the FDA has released draft and final Biosimilar Q&A guidance documents to provide enhanced clarity on scientific and regulatory considerations for the development of biosimilar and interchangeable products.

The BPCI Act requires that a marketing application for a “biological product” (that previously could have been submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)) must be submitted as a biologics license application (BLA) under section 351 of the Public Health Service Act (PHS Act). This requirement is subject to certain exceptions during a 10-year transition period ending on March 23, 2020. On March 23, 2020, the BPCI Act requires that an approved marketing application for a “biological product” under section 505 of the FD&C Act shall be deemed to be a license for the biological product (ie, an approved BLA) under section 351 of the PHS Act.