H.R. 2011 – Protecting Access to Biosimilars Act of 2019

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Updated April 14, 2026 at 3:39 AM UTC

The Protecting Access to Biosimilars Act of 2019 changes how the Public Health Service Act treats biologic products that receive a “deemed” license under the Biologics Price Competition and Innovation Act. It prevents those products from gaining extra market exclusivity and ensures anti‑evergreening rules apply to reference biologics regardless of how they were licensed. The changes affect biosimilar developers and manufacturers of original biologic reference products.

Key Provisions

Adds a new subsection (D) to 351(k)(7) stating that an approved application deemed a license under the BPCIA does not receive additional exclusivity as if it were a first‑licensed product.
Extends the anti‑evergreening provisions (subparagraph C) to apply to any reference product, whether it was first licensed or received a deemed license.

Legislative Activity

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2 earlier actions

HouseCommittee Latest Action

Referred to the Subcommittee on Health.

Health Subcommittee

April 2, 2019

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HouseIntro Referral

Introduced in House

April 1, 2019

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

April 1, 2019

HouseCommittee

Referred to the Subcommittee on Health.

Health Subcommittee

April 2, 2019

Bill Text

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Introduced in HouseIssued April 1, 2019

I

116th CONGRESS

1st Session

H. R. 2011

IN THE HOUSE OF REPRESENTATIVES

April 1, 2019

Ms. DeGette (for herself, Mr. Reed, Ms. Schrier, and Mr. Guthrie) introduced the following bill; which was referred to the Committee on Energy and Commerce

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 biologics 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)

Applicability of antievergreening provisions

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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