FDA, the Drug Regulator, Publishes the Act: Improving Access to Innovative Medical Therapies SEC7001
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This has the potential to disrupt many biotechnology markets in coming years, please read the legislation and consult the FDA site for more details, if this is an opportunity or a risk for you don’t hesitate to get in touch action@damienbove.com
In the recently enacted health insurance reform law, The Patient Protection and Affordable Care Act , (3/23/2010: Public Law No: 111-148), Title VII entitled, Improving Access to Innovative Medical Therapies, (1) describes the framework that envisions building a research and development road for enhanced discovery and FDA approval of biosimilar medicines. Based upon applications submitted, FDA will license biological products that are similar to the reference product.(2) The new law also provides certain terms for exclusivity in protecting the associated IP for both the ‘referenced biological’ and the ‘first interchangeable biological product’ of the referenced product. The public policies supporting this approach are similar to those supporting access to generic drugs.
TITLE VII—IMPROVING ACCESS TO INNOVATIVE MEDICAL THERAPIES
Subtitle A—Biologics Price Competition and Innovation
SEC. 7001. SHORT TITLE.
(a)
IN GENERAL.—This subtitle may be cited as the ‘‘Biologics Price Competition and Innovation Act of 2009’’.
(b)
SENSE OF THE SENATE.—It is the sense of the Senate that a biosimilars pathway balancing innovation and consumer interests should be established.
SEC. 7002. APPROVAL PATHWAY FOR BIOSIMILAR BIOLOGICAL PRODUCTS.
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