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Improving Access to Innovative Medical Therapies: new law

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.
The Biotechnology Industry Organization (BIO) website provides helpful information as well as advocacy webpages including “ What Legal Issues are Presented by Biosimilars”(3)
(1) http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h3590enr.txt.pdf Title VII begins Pp 686 0f 906
http://www.speaker.gov/newsroom/legislation?id=0361 for the overview of the legislation, see Speaker Nancy Pelosi’s website
(2)http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048341.htm Excerpted from FDA 101: Biological products, also known as biologics, replicate natural substances such as enzymes, antibodies, or hormones in our bodies. Biological products can be composed of sugars, proteins, or nucleic acids, or a combination of these substances. They may also be living entities, such as cells and tissues. Biologics are made from a variety of natural resources—human, animal, and microorganism—and may be produced by biotechnology methods. Most drugs consist of pure chemical substances and their structures are known. Most biologics, however, are complex mixtures that are not easily identified or characterized.
A few highlights of Title VII , see below.

-An application must include information demonstrating, among other requirements, that the biological product is biosimilar to a reference product based upon data derived from analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; animal studies (including the assessment of toxicity); a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in 1 or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product.
-Concerning safety standards for determining that the biological product is interchangeable with the reference product: if the Secretary determines that the information submitted is sufficient to show that the biological product is biosimilar to the reference product and can be expected to produce the same clinical result as the reference product in any given patient and for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch.
-Guidances may be issued, either general or specific and there will be an opportunity for the public to comment on any proposed guidance before a final one is issued., among other provisions for guidance and public input.
-The reference product gains exclusivity for 12 years. The first interchangeable biological product of a reference product gains 1 year after commercial marketing of the first interchangeable biosimilar; other terms apply in the context of other patent law scenarios.
-Other provisions also focus on pediatric studies, orphan drugs, user fees development.

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