The Supreme Court of the United States delivered its much-anticipated and historic ruling in National Federation of Independent Business v. Sebelius today, holding the major provisions of the Patient Protection and Affordable Care Act (Affordable Care Act) to be constitutional. While much of the public debate and commentary focused on the validity of the individual health insurance mandate, the Affordable Care Act also contains important provisions for the development and regulatory approval of biosimilars. Although these provisions were not challenged, questions of severability placed them in jeopardy along with the whole of the Act. Today’s 5-4 Supreme Court decision leaves the Affordable Care Act, including the biosimilars provisions, largely unchanged.
Part of the Affordable Care Act—the Biologics Price Competition and Innovation Act (BPCIA)—created a Food and Drug Administration (FDA) approval pathway for “biosimilars,” follow-on versions of biopharmaceutical products such as therapeutic proteins and antibodies. The BPCIA permits manufacturers of these follow-on versions to rely on previously disclosed pre-clinical and clinical trial data for the safety and efficacy of the biologic products, so long as the sponsor demonstrates that it (i) is “biosimilar” to a reference product (a different standard than the “bioequivalence” requirement for generic drugs), (ii) uses the same mechanism of action as the reference product, and (iii) is being proposed for previously approved condition(s) of use. In some cases, the FDA may deem a biosimilar product “interchangeable” with the reference product, providing other advantages. The BPCIA also provides a complex framework for resolving patent disputes between sponsors of a biosimilar product and the reference biologic product and resolved long-running disputes by specifying exclusivity periods for reference and certain follow-on biologics.
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