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Biosimilar Insulin Access Act of 2020

USA116th CongressHR-8190| House 
| Updated: 9/16/2020
Glenn Grothman

Glenn Grothman

Republican Representative

Wisconsin

Cosponsors (1)
Michael F. Q. San Nicolas (Democratic)

Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Biosimilar Insulin Access Act of 2020 This bill establishes that, if the Food and Drug Administration (FDA) finds that an insulin is biosimilar to a reference product, the insulin shall be deemed interchangeable with the reference product. (A biological product is biosimilar to a reference product if the two products are highly similar and have no clinically meaningful differences; the reference product generally receives FDA approval first, but the biosimilar product is typically less expensive.) Under current law, a biological product that is biosimilar to a reference product may be deemed interchangeable with the reference product only if it meets additional requirements. Current law provides that interchangeable products may be substituted for each other without the prescriber's involvement.
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Timeline
Sep 8, 2020
Introduced in House
Sep 8, 2020
Referred to the House Committee on Energy and Commerce.
Sep 16, 2020
Sponsor introductory remarks on measure. (CR H4487)
  • September 8, 2020
    Introduced in House


  • September 8, 2020
    Referred to the House Committee on Energy and Commerce.


  • September 16, 2020
    Sponsor introductory remarks on measure. (CR H4487)

Health

Blood and blood diseasesCompetition and antitrustDrug safety, medical device, and laboratory regulationDrug therapyHealth technology, devices, suppliesIntellectual propertyLicensing and registrationsPrescription drugs

Biosimilar Insulin Access Act of 2020

USA116th CongressHR-8190| House 
| Updated: 9/16/2020
Biosimilar Insulin Access Act of 2020 This bill establishes that, if the Food and Drug Administration (FDA) finds that an insulin is biosimilar to a reference product, the insulin shall be deemed interchangeable with the reference product. (A biological product is biosimilar to a reference product if the two products are highly similar and have no clinically meaningful differences; the reference product generally receives FDA approval first, but the biosimilar product is typically less expensive.) Under current law, a biological product that is biosimilar to a reference product may be deemed interchangeable with the reference product only if it meets additional requirements. Current law provides that interchangeable products may be substituted for each other without the prescriber's involvement.
View Full Text

Suggested Questions

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

Timeline
Sep 8, 2020
Introduced in House
Sep 8, 2020
Referred to the House Committee on Energy and Commerce.
Sep 16, 2020
Sponsor introductory remarks on measure. (CR H4487)
  • September 8, 2020
    Introduced in House


  • September 8, 2020
    Referred to the House Committee on Energy and Commerce.


  • September 16, 2020
    Sponsor introductory remarks on measure. (CR H4487)
Glenn Grothman

Glenn Grothman

Republican Representative

Wisconsin

Cosponsors (1)
Michael F. Q. San Nicolas (Democratic)

Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Blood and blood diseasesCompetition and antitrustDrug safety, medical device, and laboratory regulationDrug therapyHealth technology, devices, suppliesIntellectual propertyLicensing and registrationsPrescription drugs