This legislative proposal aims to streamline the regulatory review process for biosimilar biological products by making a targeted amendment to the Public Health Service Act. Specifically, it modifies Section 351(k)(5) of the Act, which governs the approval pathway for these products. The bill achieves this streamlining by striking an existing subparagraph (B) and subsequently redesignating subparagraph (C) as the new subparagraph (B). This technical adjustment is intended to simplify the requirements or procedures involved in the review and approval of biosimilar biological products, potentially accelerating their availability to the market.
A bill to amend the Public Health Service Act to streamline the review of biosimilar biological products.
USA119th CongressS-5059| Senate
| Updated: 7/21/2026
This legislative proposal aims to streamline the regulatory review process for biosimilar biological products by making a targeted amendment to the Public Health Service Act. Specifically, it modifies Section 351(k)(5) of the Act, which governs the approval pathway for these products. The bill achieves this streamlining by striking an existing subparagraph (B) and subsequently redesignating subparagraph (C) as the new subparagraph (B). This technical adjustment is intended to simplify the requirements or procedures involved in the review and approval of biosimilar biological products, potentially accelerating their availability to the market.