H.R.5629 - Pathway for Biosimilars Act
To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. view all titles (2)
All Bill Titles
- Short: Pathway for Biosimilars Act as introduced.
- Official: To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. as introduced.
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Latest Action Apr 14, 2008Referred to the Subcommittee on Cour... Related Bills (0) & Issues (29)
Official Summary
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 licensure under this Act of a biological product containing specified agents or toxins.
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.
...Read the Rest
Recent News Coverage
New US biosimilars bill a disappointing distraction, says GPhA
HR 5629, the bipartisan Pathway for Biosimilars Act introduced in the House by Representatives Anna Eshoo (Democrat, California) and Representative Joe ...
California Healthcare Institute Supports Introduction of ...
... March 14, to Congresswoman Anna Eshoo (D-Menlo Park) commending her for the introduction of HR 5629, the “Pathway for Biosimilars Act,” legislation that ...
Recent Blog Coverage
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View Top Rated
Patent Docs: Top Stories of 2008: #9 to #6
Five follow-on biologics bills were introduced during the 110th Congress: H.R. 1956 (which provides twelve years of data exclusivity and two years of market exclusivity), S. 1695 and H.R. 5629 (which provide four years of data ...
Patent Docs: Teva CEO Predicts Passage of Follow-on Biologics Bill ...
We also reported last summer that the Biotechnology Industry Organization (BIO) indicated that either H.R. 1956 (providing fourteen years of exclusivity), H.R. 5629 (providing twelve years of exclusivity), or S. 1695 (also providing ...
GoozNews: Biosimilars, Biogenerics Not the Same
Anna Eshooâs H.R.5629 each call for testing drugs for safety, purity and âpotency.â The FDA uses potency as a synonym for efficacy. In other words, all three bills would mandate clinical trial effectiveness testing â the expensive ...
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U.S. Congress - H.R.5629 Pathway for Biosimilars Act



