US FDA ties up another Biosimilars loose end

The US Food and Drug Administration issuance of three long-awaited and highly anticipated draft biosimilar guidances earlier this year (The Pharma Letter February 10) seems to have hardly whet the appetite of industry for information on its interpretation of Section 351(k) of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), comments Kurt Karst of Hyman, Phelps & McNamara on the law firm's FDA Law Blog.

Shortly after the FDA released the three draft biosimilars guidances, the agency denied outstanding requests in two citizen petitions submitted to the FDA in April 2003 (Docket No FDA-2003-P-0003) and April 2004 (Docket No FDA-2004-P-0214) by the Biotechnology Industry Organization and biotech firm Genentech (now part of Roche), concerning the submission and approval of 505(b)(2) applications under the FDC Act for “biotechnology-derived products” or “follow-on therapeutic proteins.”

Apparently there was a third pre-BPCIA citizen petition submitted to the FDA in January 2009 (Docket No FDA-2009-P-0004), noted Mr Karst. The two-page citizen petition submitted by Therapeutic Proteins simply requests that the FDA “allow acceptance of applications for marketing authorization of equivalent forms of biological drugs” (ie, certain protein and peptide products); or, as the FDA’s rephrases the “ask”: “that FDA accept an ANDA submitted under section 505(j) of the FD&C Act for a protein or peptide product intended to be the ‘same’ as a product that previously was approved under either the FD&C Act or the PHS Act.” The FDA’s six-page response granting in part and denying in part the petition appears to provide further insight into FDA’s thinking on biosimilars approval.