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Protecting Access to Biosimilars Act of 2019

USA116th CongressHR-2011| House 
| Updated: 4/2/2019
Diana DeGette

Diana DeGette

Democratic Representative

Colorado

Cosponsors (5)
Kim Schrier (Democratic)Brett Guthrie (Republican)Glenn Grothman (Republican)Dan Crenshaw (Republican)Tom Reed (Republican)

Health Subcommittee, Energy and Commerce 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 1, 2019
Introduced in House
Apr 1, 2019
Referred to the House Committee on Energy and Commerce.
Apr 2, 2019
Referred to the Subcommittee on Health.
Apr 11, 2019

Latest Companion Bill Action

S 116-1140
Introduced in Senate
  • April 1, 2019
    Introduced in House


  • April 1, 2019
    Referred to the House Committee on Energy and Commerce.


  • April 2, 2019
    Referred to the Subcommittee on Health.


  • April 11, 2019

    Latest Companion Bill Action

    S 116-1140
    Introduced in Senate

Health

Related Bills

  • S 116-1140: 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 CongressHR-2011| House 
| Updated: 4/2/2019
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 1, 2019
Introduced in House
Apr 1, 2019
Referred to the House Committee on Energy and Commerce.
Apr 2, 2019
Referred to the Subcommittee on Health.
Apr 11, 2019

Latest Companion Bill Action

S 116-1140
Introduced in Senate
  • April 1, 2019
    Introduced in House


  • April 1, 2019
    Referred to the House Committee on Energy and Commerce.


  • April 2, 2019
    Referred to the Subcommittee on Health.


  • April 11, 2019

    Latest Companion Bill Action

    S 116-1140
    Introduced in Senate
Diana DeGette

Diana DeGette

Democratic Representative

Colorado

Cosponsors (5)
Kim Schrier (Democratic)Brett Guthrie (Republican)Glenn Grothman (Republican)Dan Crenshaw (Republican)Tom Reed (Republican)

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • S 116-1140: 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