House Bill 2011
116th Congress(2019-2020)
Protecting Access to Biosimilars Act of 2019
Introduced
Introduced in House on Apr 1, 2019
Origin Chamber
House
Type
Bill
Bill
The primary form of legislative measure used to propose law. Depending on the chamber of origin, bills begin with a designation of either H.R. or S. Joint resolution is another form of legislative measure used to propose law.
Bill Number
2011
Congress
116
Policy Area
Health
Health
Primary focus of measure is science or practice of the diagnosis, treatment, and prevention of disease; health services administration and funding, including such programs as Medicare and Medicaid; health personnel and medical education; drug use and safety; health care coverage and insurance; health facilities. Measures concerning controlled substances and drug trafficking may fall under Crime and Law Enforcement policy area.
No House votes have been held for this bill.
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.)
April 1, 2019
04/02/2019
Referred to the Subcommittee on Health.
04/01/2019
Referred to the House Committee on Energy and Commerce.
04/01/2019
Introduced in House
Public Record
Record Updated
Nov 1, 2022 6:47:25 PM