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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.)

S1140-116, S1895-116,

House committee actions Actions

Committee
Apr. 02 2019	Referred to the Subcommittee on Health.

House floor actions Actions

IntroReferral
Apr. 01 2019	Referred to the House Committee on Energy and Commerce.

Library of Congress Actions

IntroReferral
Apr. 01 2019	Introduced in House Introduced in House

House bill HR2011-116

Protecting Access to Biosimilars Act of 2019

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