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S. 1140

Referred to Committee

Protecting Access to Biosimilars Act of 2019

Introduced 4/11/2019•116th Congress•Senate

Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

4/11/2019 • Senate

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.)

Introduced in Senate • 4/11/2019

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Topics & Subjects

Policy Area: Health
AllergiesBlood and blood diseasesDrug safety, medical device, and laboratory regulationHealth promotion and preventive careHealth technology, devices, suppliesImmunology and vaccinationLicensing and registrations

Congressional Votes (0)

No recorded votes yet

Roll call votes will appear here as the bill moves through Congress

Related Federal Spending

Sponsor & Cosponsors (3)

Party Breakdown

1
Democrats
2
Republicans
0
Independents

Sponsor

S[
Sen. Smith, Tina [D-MN]

Democrat • MN

Sponsored 4/11/2019

Cosponsors (2)

S[
Sen. Cassidy, Bill [R-LA]

R-LA

Joined 4/11/2019

S[
Sen. Cramer, Kevin [R-ND]

R-ND

Joined 5/7/2019

Bill Journey

Originated in the Senate

Introduced

April 11, 2019

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Committee Review

Floor Debate

Passed Chamber

Other Chamber

President

Enacted into Law

Text Versions (1)

Introduced in Senate4/11/2019

Details

Bill TypeS
Current StatusReferred to Committee
Cosponsors2