FDA Response to Citizen Petition Confirms that the BPCIA is the Only Abbreviated Route for Drugs Previously Approved Via a BLA

FDA recently published its Response to a 2009 Citizen Petition from Therapeutic Proteins, Inc. which requested FDA “exercise its authority and make necessary amendments to its rules to allow submission of biological drug marketing authorization applications [including BLAs submitted under the PHS Act] under aNDA ….”  In short, FDA concluded that there is no ANDA end-around to the recently enacted biosimilar approval pathway under the BPCIA:

The 505(b)(2) and 505(j) approval pathways are available only for products for which the listed drug relied upon or RLD, respectively, was approved under section 505(c) of the FD&C Act.  Because the 505(j) pathway is not available for a proposed product that seeks to rely upon a biological product licensed under section 351(a) of the PHS Act, your Petition is denied in part.  The BPCI Act was enacted after the submission of your Petition.  A sponsor seeking to submit an abbreviated marketing application for a biological product that can be demonstrated to be “highly similar” (biosimilar) to, or interchangeable with, a reference product licensed under section 351(a) of the PHS Act may submit a 351(k) application. 

Response at 5.  The authors of the FDA Law Blog have written an interesting post about this and two earlier Citizen Petition Responses concerning biosimilars:  You Had Us At “Biosimilars,” FDA; Agency Ties Up Yet Another Biosimilars Loose End With Petition Response Concerning Certain “Biological Drugs.”

We’re still awaiting the first biosimilar litigation and/or approval under the BPCIA to see whether the biosimilar route is truly going to be an attractive opportunity in the U.S.