Skip to main content
HR 2011 116th Congress House 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

Introduced: April 1, 2019 Introduced by: DeGette, Diana Democratic · Colorado See on congress.gov
Sign in to write a letter Sign in to watch
This bill died when the 116th Congress ended
It never became law before the 116th Congress (2019–2020) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Apr 2, 2019
Referred to the Subcommittee on Health.
Apr 1, 2019
Introduced in House
Apr 1, 2019
Referred to the House Committee on Energy and Commerce.
 Ask about this bill AI · grounded in the bill text

Have a question about what this bill does? Ask in plain English; the answer is drawn from the bill's actual text and official record, and it'll tell you when something isn't in the text rather than guess.

AI answers can be imperfect; always confirm against the full bill text.

 Plain-English summary Congressional Research Service

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 April 2, 2019

Referred to the Subcommittee on Health.

 Related & companion bills 2
  • S 1895 Related bill Lower Health Care Costs Act
  • S 1140 Related bill Protecting Access to Biosimilars Act of 2019
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 5
All 5 Democratic 1 Republican 3
R
Crenshaw, Dan
Texas · Jun 27, 2019
 R
Grothman, Glenn
Wisconsin · May 22, 2019
 R
Guthrie, Brett
Kentucky · Apr 1, 2019
Reed, Tom
· Apr 1, 2019
 D
Schrier, Kim
Washington · Apr 1, 2019
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 2011: Protecting Access to Biosimilars Act of 2019. 116th Congress. Open America. https://openamerica.io/bill/116-HR-2011/
MLA
"H.R. 2011: Protecting Access to Biosimilars Act of 2019." 116th Congress, 2026, Open America, https://openamerica.io/bill/116-HR-2011/.
Bluebook (legal)
H.R. 2011, 116th Cong. (2026), https://openamerica.io/bill/116-HR-2011/.
Markdown link
[H.R. 2011: Protecting Access to Biosimilars Act of 2019](https://openamerica.io/bill/116-HR-2011/)
Report a problem