Summary: S.1140 — 116th Congress (2019-2020)All Information (Except Text)

There is one summary for S.1140. Bill summaries are authored by CRS.

Shown Here:
Introduced in Senate (04/11/2019)

Protecting Access to Biosimilars Act of 2019

This bill excludes biological products that were initially licensed under the Federal Food, Drug, and Cosmetic Act (FD&C Act) (e.g., insulin) from the exclusivity protections that delay the licensure of biosimilar products under the Public Health Service Act (PHS Act). (The Biologics Price Competition and Innovation Act of 2009 generally requires that biological products approved under the FD&C Act are treated as though they were approved under the PHS Act through March 23, 2020.)