H.R. 2011

Referred to Committee

Protecting Access to Biosimilars Act of 2019

Introduced 4/1/2019•116th Congress•House

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Latest Action

Referred to the Subcommittee on Health.

4/2/2019 • House

Summary

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.)

Introduced in House • 4/1/2019

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Topics & Subjects

Policy Area: Health

AllergiesBlood and blood diseasesDrug safety, medical device, and laboratory regulationHealth promotion and preventive careHealth technology, devices, suppliesImmunology and vaccinationLicensing and registrations