S.1695: A bill to amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, to promote innovation in the life sciences, and for other purposes.
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A bill to amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, to promote innovation in the life sciences, and for other purposes. 6/26/2007--Introduced. 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 [...]
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