Amgen, Inc. (“Amgen”) has brought the discussion of the procedure for biosimilar applications from the courts to the FDA by filing a Citizen Petition (Docket No. FDA-2014-P-1771) on October 29, 2014 (“Petition”) requesting that the FDA mandate compliance with the framework for biosimilar applications laid out by the Biologics Price Competition and Innovation Act (“BPCIA”).

As we discussed in last week’s Client Alert entitled Left Without a Partner: Amgen Sues Sandoz for Refusing to Dance in Accordance with BPCIA Patent Procedures, Amgen is concerned about companies filing biosimilar applications under section 351(k) of the Public Health Service Act and subsequently choosing not to engage in the “patent dance” information exchange procedures set forth in the BPCIA.

As set forth in our previous Client Alert, the BPCIA lays out a detailed procedure commonly referred to as the “patent dance” in section 351(l) under which a holder of a branded biologic, such as Amgen, and a biosimilar applicant, such as Sandoz, are to engage in a series of timed exchanges of information with the goal of determining which, if any, of the brand holder’s patents will be litigated by the parties.

In its Petition, Amgen seeks to require that FDA mandate that biosimilar applications “include certification by the applicant that the applicant will timely comply with § 351(l)(2)(A) by providing the reference product sponsor with a copy of the biosimilar application and information that describes the process(es) used to manufacture the biosimilar product that is the subject of that application. This certification should be required for all biosimilar applications that have not been accepted for review by the FDA.”[1] (Petition at pp. 1, 5.)

Amgen argues that allowing non-compliance with the BPCIA procedures regarding notification of filing of the biosimilar application would undermine the entire BPCIA. For example, Amgen notes that “[i]f the biosimilar applicant does not disclose the biosimilar application and manufacturing information, the reference product sponsor may not know that an application referencing its product has been submitted.” (Petition at p. 2.)

Amgen further notes that it believes Sandoz’s proposal of an alternate disclosure mechanism for the biosimilar application, including conditions not found in the BPCIA, was not sufficient compliance. Amgen argues that the “unless otherwise agreed to language” of the BCPIA applies only to negotiating alternate confidentiality provisions, not to proposing an entire alternate information exchange framework.

Effectively, the requested certification of compliance would prevent parties from negotiating the “patent dance” information exchange outside the framework laid out by the BPCIA.

Notes:

[1] Even if FDA takes the action requested in the Petition, it will not resolve Amgen’s dispute with Sandoz, as Sandoz’s application has already been accepted for review by FDA.