FDA Issues Draft Guidance Documents for Biosimilars


On February 9, 2012, in a much anticipated press release, FDA announced the publication of draft guidance documents relating to the development of follow-on biologics for previously approved therapeutic proteins under the Biologics Price Competition and Innovation Act (the BPCIA). The guidance documents are general in nature and leave some questions unanswered, but represent the first step in removing uncertainties associated with the biosimilar approval pathway.

The BPCIA was signed into law on March 23, 2010, as part of the Patient Protection and Affordable Care Act (the Healthcare Reform Act), creating an FDA approval pathway for follow-on versions of biological products such as therapeutic proteins. It also provides exclusivity periods for reference biologic and certain follow-on products and a complex framework for resolving patent disputes between sponsors of the biosimilar product and the reference biologic product.

The BPCIA created a purportedly streamlined approval process and other similar provisions for follow-on biologics. Given the various complexities in structure and manufacturing processes, approval of a follow-on product under the BPCIA requires more than the showing of “bioequivalence” that is required for generic drugs. The sponsor of the follow-on biologic must demonstrate that it (i) is “biosimilar” to a reference product, (ii) uses the same mechanism of action, to the extent known for the reference product, and (iii) is being proposed for previously approved condition(s) of use. A biosimilar product may be deemed “interchangeable” if further requirements are met.

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