S. 1695 would amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and it would promote innovation in the life sciences.
Detailed Summary
Biologics Price Competition and Innovation Act of 2007 - 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 license the biological product if it is biosimilar to or interchangeable with the reference product. Allows a determination of interchangeability if the product is: (1) biosimilar to the reference product and can be expected to produce the same clinical result in any given patient; and (2) the risk in terms of safety or diminished efficacy of alternating or switching between the products is not greater than the risk of using the reference product without switching.
Prohibits the Secretary from determining that a second or subsequent biological product is interchangeable for any condition of use until one year after the first commercial marketing of the first product to be approved as interchangeable for that reference product.
Prohibits the Secretary from making approval of an application under this Act f effective until 12 years after the date on which the reference product was first licensed.
Authorizes the Secretary to issue product class-specific guidance.
Sets forth provisions governing patent infringement actions related to the exchange of confidential information, good faith negotiations, and the filing of an infringement action.
Requires the Secretary to: (1) develop recommendations with respect to the goals for the process for the review of biosimilar biological product applications; and (2) collect and evaluate data regarding the cost of reviewing such applications.
Status of the Legislation
Latest Major Action: 6/27/2007: Senate committee/subcommittee actions. Status: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Points in Favor
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Points Against
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Visitor Comments
Ryan
August 13, 2007, 1:06pm (report abuse)One of the reasons why generic drugs are good for the consumer is that the companies don't have to do clinical trials. There are already methods of characterization which are acceptable for showing biological equivalence. By forcing follow-on biologic producers to do clinical trials (which they don't have to do for chemical, small-molecule drugs), this will increase cost to the consumer and reduce the level of treatment available to those who need it most.
m
November 7, 2007, 1:18pm (report abuse)Clinical trials are necessary for biosimilars though because regular generics (small molecules) have no risk of triggering an immune system reaction. The science is different for the two types of generics and thus clinical requirements are different