Pathway for Biosimilars Act

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IntroducedPassed one chamberPassed both chambersBecame law (gold)Resolution agreed to (full, dark)Failed or vetoed (gray)

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Never voted on. It didn't reach a floor vote before the 111th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

D EshooSponsor

149 cosponsors · 87 D, 62 R

R McMorris Rodgers PR

43 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.

Pathway for Biosimilars Act - Amends the Public Health Service Act to allow a person to submit an application for licensure of a biological product based on its similarity to a licensed biological product (the reference product).

What it does: CRS summary · Introduced in House · Mar 17, 2009

Requires the Secretary of Health and Human Services to approve the application if: (1) the biological product is biosimilar to the reference product with respect to each condition of use for which the reference product is approved; and (2) the applicant consents to the inspection of the facility that is the subject of the application.

Sets forth requirements for a determination by the Secretary that a biological product is interchangeable with a reference product.

Prohibits a biological product from being evaluated against more than one reference product.

Prohibits licensure under this Act of a biological product containing specified agents or toxins or a schedule I or II controlled substance unless the Secretary determines there would be no increased risk to the security or health of the public from licensing such a biological product.

Prohibits the Secretary from making approval of an application under this Act effective until 12 yeas after the date on which the reference product was first licensed.

Provides for confidentiality of information received pursuant to this Act.

Sets forth provisions governing patent infringement actions related to this Act.

Deems as patent infringement the submission of a statement under this Act by the applicant setting forth reasons why the making, use, or sale of the biosimilar product would not infringe the patent, or why the patent is invalid or unenforceable, if the purpose of such submission is to obtain approval to engage in the commercial manufacture, use, or sale before the expiration of such patent.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: Pathway for Biosimilars Act

Latest action (Mar 18, 2009): Referred to the Subcommittee on Health.

Policy area: Health · Origin: House · Introduced: Mar 17, 2009

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.