Protecting Access to Biosimilars Act of 2019

Bill: 116-s-1140
Sponsor: full_name: Sen. Smith, Tina [D-MN]
Introduced: 2019-04-11
Policy area: Health
Subjects: Allergies

Blood and blood diseases

Drug safety, medical device, and laboratory regulation

Health promotion and preventive care

Health technology, devices, supplies

Immunology and vaccination

Licensing and registrations
Latest action: action_date: 2019-04-11
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2019-04-11
action_desc: Introduced in Senate
text: <p><b>Protecting Access to Biosimilars Act of 2019</b></p> <p>This bill excludes biological products that were initially licensed under the Federal Food, Drug, and Cosmetic Act (FD&amp;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&amp;C Act are treated as though they were approved under the PHS Act through March 23, 2020.)</p>

tv_txt: II 116th CONGRESS 1st Session S. 1140 IN THE SENATE OF THE UNITED STATES April 11, 2019 Ms. Smith (for herself and Mr. Cassidy ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009.

1. Short title This Act may be cited as the Protecting Access to Biosimilars Act of 2019 . 2. Treatment of biological products deemed licensed Section 351(k)(7) of the Public Health Service Act ( 42 U.S.C. 262(k)(7) ) is amended by adding at the end the following: (D) Deemed licenses (i) No additional exclusivity through deeming An approved application that is deemed to be a license for a biological product under this section pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 shall not be treated as having been first licensed under subsection (a) for purposes of subparagraphs (A) and (B). (ii) Limitation on exclusivity applies to any reference product Subparagraph (C) shall apply to any reference product, without regard to whether— (I) such product was first licensed under subsection (a); or (II) the approved application for such product was deemed to be a license for a biological product as described in clause (i). .