Protecting Access to Biosimilars Act of 2019
- Last Action
- 4/2/2019
Actions
- 2019-04-02Referred to the Subcommittee on Health.
- 2019-04-01Referred to the House Committee on Energy and Commerce.
- 2019-04-01Introduced in House
- 2019-04-01Introduced in House
CRS Summary
As of 2019-04-01 (00)
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.)
Cosponsors (5)
- Tom Reed (R-NY)
- Kim Schrier (D-WA)
- Brett Guthrie (R-KY)
- Glenn Grothman (R-WI)
- Dan Crenshaw (R-TX)
Subjects
- Allergies
- Blood and blood diseases
- Drug safety, medical device, and laboratory regulation
- Health promotion and preventive care
- Health technology, devices, supplies
- Immunology and vaccination
- Licensing and registrations
Sourced from Congress.gov (public domain).
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.