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Latest Update: Sunday, October, 12th 2008
To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. 3/13/2008--Introduced. 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 [...] show full description
- 04/14/2008 - Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.
- 03/13/2008 - Sponsor introductory remarks on measure. (CR E401-402)
- 03/13/2008 - 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.
- 03/13/2008 - Referred to House Energy and Commerce
- 03/13/2008 - Referred to House Judiciary
show all actions- 04/14/2008 - Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.
- 03/13/2008 - Sponsor introductory remarks on measure. (CR E401-402)
- 03/13/2008 - 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.
- 03/13/2008 - Referred to House Energy and Commerce
- 03/13/2008 - Referred to House Judiciary
- 03/13/2008 - Referred to the Subcommittee on Health.
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