United States 116th Congress Status: In Committee 1 D cosponsors

HR 2011 — Protecting Access to Biosimilars Act of 2019

Last action — Referred to the Subcommittee on Health.

  1. ✓
    Introduced
  2. 2
    In Committee
  3. 3
    Passed House
  4. 4
    Passed Senate
  5. 5
    To Executive
  6. 6
    Enacted

This bill died with 116th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there are no live odds of enactment. It would have to be reintroduced in the current session to move again.

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.)

Bill Text

How this bill changes current law

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Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill adds provisions regarding the treatment of certain biological products deemed to have a biologics license, impacting their exclusivity under current law.

  • 42 U.S.C. 262(k)(7)

    (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).

    This change prevents certain licensed biological products from receiving additional exclusivity based on their deemed license status.

Action History

  1. Introduced in House

  2. Introduced in House

  3. Referred to the House Committee on Energy and Commerce.

  4. Referred to the Subcommittee on Health.

Sponsors

Sponsorship breakdown

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1 sponsors · 0 co-sponsors · 546 not signed on

Sponsors (1)

Co-sponsors (0)

None.

Not signed on (546)

546 members have not signed on to this bill.

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"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

Whip count is in markup. Polling the chamber and every recorded vote this session. Only the first open is slow. It’s instant for you after this. Calling the roll · Tallying · Engrossing

Subjects

healthcare health-insurance
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Frequently asked questions

What does HR 2011 do?
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.)
Who sponsors HR 2011?
HR 2011 is sponsored by DeGette, Diana (Democratic).
What is the current status of HR 2011?
This bill died with 116th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track HR 2011?
Track HR 2011 free on One Click Politics — get push/email alerts when it moves.

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Last checked for changes 3 months ago · updated continuously

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