Title: Protecting Access to Biosimilars Act of 2019
Policy area: Health

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.)

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 1140 Introduced in Senate (IS)]

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116th CONGRESS
  1st Session
                                S. 1140

 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.


_______________________________________________________________________


                   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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Protecting Access to Biosimilars Act 
of 2019''.

SEC. 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).''.
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