H.R. 1548 would amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products.
Detailed Summary
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).
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.
Status of the Legislation
Latest Major Action: 3/17/2009: Referred to House committee. Status: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Points in Favor
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Points Against
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Visitor Comments
lucile darcy
September 16, 2009, 2:28pm (report abuse)is not consumer friendly enough, too long a period of monopoly
Jack E. Martinelli
September 22, 2009, 10:08am (report abuse)Recently, I received a postcard mailing from the "Pharmaceutical Research & Manufacturers of America", of which six were named, urging me to write my Congressman William Delahunt in support of this bill. The info had little to nothing about the specifics or details of the bill. It had the unmistakable appearance of smoke, back patting, and shill.
We need expert opinion from knowledgeable advocates for the public about this issue.
2009-09-22 END