Yesterday, the U.S. Food and Drug Administration released three draft guidance documents designed to assist industry in developing biosimilars and implementing the new abbreviated biologics approval pathway under section 351(k) of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), signed into law in March 2010 as part of the Patient Protection and Affordable Care Act.  This Client Alert provides a detailed summary of the draft guidance entitled “Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.”  Please refer to our Client Alert entitled “FDA Releases Long-Awaited Draft Guidance on Biosimilar Product Development” for an overview of all three draft guidance documents.

FDA Tells Sponsors: “Step-by-Step” and “Totality of Evidence.”

FDA states that the guidance applies to biosimilar applications filed under section 351(k) of the PHS Act, but “may be informative” for sponsors of NDAs filed under section 505(b)(2) of the FDC Act.  Encouraging biosimilar sponsors to undertake a “stepwise approach to demonstrating biosimilarity” in which FDA will “consider the totality of the evidence provided by a sponsor,” the draft guidance suggests that developing sufficient analytical, structural, and toxicological data could permit FDA and sponsor to pursue “a selective and targeted approach” to subsequent human pharmacokinetics (PK), pharmacodynamics (PD), clinical immunogenicity, and comparative clinical studies. (Guidance at 2, 7.)

To achieve these ends, and citing its discretionary authority to waive analytical, preclinical, and clinical studies, FDA recommends that biosimilar sponsors meet and have “early discussions” with the Agency “to present their product development plans and establish a schedule of milestones that will serve as landmarks for future discussions with the Agency” to “facilitate biosimilar development.”  (Guidance at 4, 21.)

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