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Main Subject: Health

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.)

HR2011-116, S1895-116,

Senate Actions

IntroReferral
Apr. 11 2019	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Library of Congress Actions

IntroReferral
Apr. 11 2019	Introduced in Senate

Senate bill S1140-116

Protecting Access to Biosimilars Act of 2019

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