A bill to amend the Public Health Service Act to streamline the review of biosimilar biological products.

This bill would change the federal law that governs how the Food and Drug Administration (FDA) reviews applications for biosimilar biological products, which are medicines highly similar to an already-approved biological drug. It would remove subparagraph (B) from Section 351(k)(5) of the Public Health Service Act. That subparagraph sets a rule about how these applications are reviewed; current law generally assigns review to the same FDA division that handled the original product. The bill would then renumber the following subparagraph (C) as subparagraph (B).

Full text and official record on Congress.gov

Sponsors

• Ashley Moody Republican sponsor
• 3 cosponsors