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H.R. 8190

BillFederalHouseIntroduced
To amend the Public Health Service Act to deem any insulin that is determined by the Secretary to be biosimilar to the reference product to be interchangeable with the reference product, and for other purposes.
About This Bill
Introduced
Latest Action · September 16, 2020
Sponsor introductory remarks on measure. (CR H4487)
Congress
116th (2019–2021)
Introduced
September 8, 2020
Cosponsors (1)
1D 0R
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Summary

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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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