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S. 1140Senate116th Congress (2019-2021)In Committee

Protecting Access to Biosimilars Act of 2019

Sponsored by Tina SmithSen. Tina Smith (D-MN)
Introduced April 11, 2019

AI-Generated Summary

Updated April 14, 2026 at 4:15 AM UTC

The Protecting Access to Biosimilars Act of 2019 amends the Public Health Service Act to change how “deemed” licenses for biologic products are treated. It prevents those products from receiving extra market exclusivity and makes the existing exclusivity limits apply to any reference product, whether it was first licensed or only deemed licensed. The change is intended to improve access to biosimilars and affects both biosimilar developers and holders of reference biologics.

Key Provisions

  • Adds a new subsection stating that an approved application deemed a license under the Biologics Price Competition and Innovation Act does not receive additional exclusivity as a first‑licensed product.
  • Specifies that the exclusivity limitation for reference products applies regardless of whether the product was first licensed or only deemed licensed.

Legislative Activity

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1 earlier action
SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

April 11, 2019

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SenateIntro Referral

Introduced in Senate

April 11, 2019

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

April 11, 2019

Bill Text

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Introduced in SenateIssued April 11, 2019

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).

.