S 1140
116th Congress
Senate
Health
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
Protecting Access to Biosimilars Act of 2019
Everywhere this bill has been
2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Apr 11, 2019
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Apr 11, 2019
Introduced in Senate
Plain-English summary
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.)
What's happening now
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Committees of jurisdiction
1