The U.S. Food and Drug Administration published its long-awaited draft guidance on the development of biosimilar products today (see FDA press release), taking a significant step toward the utilization of § 351(k) of the Public Health Service Act (amended by the Biologics Price Competition and Innovation Act (BPCIA)).  Section 351(k) creates a biologics pathway that is reminiscent of the pathway set forth by the Hatch-Waxman Act for small molecule drugs.  The FDA promised that it would release the guidance materials by the end of 2011, but failed to meet this deadline, most likely due to the complexities of the many issues surrounding biosimilar products.  The agency indicates that these guidance documents provide the FDA's current thinking on key scientific and regulatory factors involved in submitting applications for biosimilar products.  As expected, the FDA is seeking public comment on each of draft guidance documents within 60 days of the notice of publication in the Federal Register.

The BPCIA and section 351(k) have been in force since March 2010.  However, without any indication as to how the statute will be implemented by the FDA, the pathway has not gained much traction as an alternative to filing a full Biologics License Application (BLA) for a biologic under the PHSA (42 U.S.C. § 262).  Today's guidance documents provide some direction to companies involved in biosimilar development regarding the factors the FDA will use to evaluate whether to grant a license to their biosimilar products in the United States, despite the draft status of the guidance documents.  Now the biologics industry awaits public notification of the first 351(k) application filing, which under the statute, would set in motion a complex exchange of documents pertaining to the biologic, eventually progressing to litigation between the reference drug BLA holder and the 351(k) biosimilar applicant.

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