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.
Get AI-generated questions to help you understand this bill better
Timeline
Introduced in House
Referred to the House Committee on Energy and Commerce.
Sponsor introductory remarks on measure. (CR H4487)
Introduced in House
Referred to the House Committee on Energy and Commerce.
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.
Blood and blood diseasesCompetition and antitrustDrug safety, medical device, and laboratory regulationDrug therapyHealth technology, devices, suppliesIntellectual propertyLicensing and registrationsPrescription drugs