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Bill > HR3379


US HR3379

US HR3379
PRICED Act Price Relief, Innovation, and Competition for Essential Drugs Act


summary

Introduced
06/20/2019
In Committee
06/21/2019
Crossed Over
Passed
Dead
12/31/2020

Introduced Session

116th Congress

Bill Summary

To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years. This bill allows biosimilars to be marketed five years after the reference brand-name biological product is licensed. Currently, brand-name biological products are provided a 12-year marketing-exclusivity period. This shortened marketing-exclusivity period applies only to biological products licensed by the Food and Drug Administration after enactment of this bill.

AI Summary

This bill, the Price Relief, Innovation, and Competition for Essential Drugs Act (PRICED Act), amends the Public Health Service Act to shorten the exclusivity period for brand-name biological products from 12 years to 5 years. This means that biosimilar products, which are similar but not identical to the original biological product, can be marketed and sold 5 years after the reference brand-name biological product is licensed by the Food and Drug Administration (FDA). The changes made by this bill only apply to biological products licensed by the FDA after the enactment of this legislation.

Committee Categories

Business and Industry, Health and Social Services

Sponsors (23)

Last Action

Referred to the Subcommittee on Health. (on 06/21/2019)

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