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Protecting Access to Biosimilars Act of 2019

USA116th CongressS-1140| Senate 
| Updated: 4/11/2019
Tina Smith

Tina Smith

Democratic Senator

Minnesota

Cosponsors (2)
Bill Cassidy (Republican)Kevin Cramer (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.)
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Timeline
Apr 2, 2019

Latest Companion Bill Action

HR 116-2011
Referred to the Subcommittee on Health.
Apr 11, 2019
Introduced in Senate
Apr 11, 2019
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • April 2, 2019

    Latest Companion Bill Action

    HR 116-2011
    Referred to the Subcommittee on Health.


  • April 11, 2019
    Introduced in Senate


  • April 11, 2019
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Related Bills

  • HR 116-2011: Protecting Access to Biosimilars Act of 2019
  • S 116-1895: Lower Health Care Costs Act
AllergiesBlood and blood diseasesDrug safety, medical device, and laboratory regulationHealth promotion and preventive careHealth technology, devices, suppliesImmunology and vaccinationLicensing and registrations

Protecting Access to Biosimilars Act of 2019

USA116th CongressS-1140| Senate 
| Updated: 4/11/2019
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.)
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Apr 2, 2019

Latest Companion Bill Action

HR 116-2011
Referred to the Subcommittee on Health.
Apr 11, 2019
Introduced in Senate
Apr 11, 2019
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • April 2, 2019

    Latest Companion Bill Action

    HR 116-2011
    Referred to the Subcommittee on Health.


  • April 11, 2019
    Introduced in Senate


  • April 11, 2019
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Tina Smith

Tina Smith

Democratic Senator

Minnesota

Cosponsors (2)
Bill Cassidy (Republican)Kevin Cramer (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 116-2011: Protecting Access to Biosimilars Act of 2019
  • S 116-1895: Lower Health Care Costs Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
AllergiesBlood and blood diseasesDrug safety, medical device, and laboratory regulationHealth promotion and preventive careHealth technology, devices, suppliesImmunology and vaccinationLicensing and registrations