Amgen Requests FDA Require Certification of Compliance with Biosimilar Pathway

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Amgen wants the regulatory agency to ensure biosimilar applicants follow the rules of the patent dispute resolution process delineated by the BPCIA.

To top off its lawsuit against Sandoz, Amgen filed a citizen’s petition on Oct. 29, 2014 requesting that FDA require biosimilar applicants to comply with the process laid out by the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Amgen requests that this certification be mandatory for all biosimilar applications that have not been accepted for review by FDA as a preemptive measure to prevent noncompliance and resolve any patent disputes before a biosimilar is approved and commercialized.

As reported last week, Amgen alleges Sandoz purposely withheld manufacturing information that it was supposed to share with the innovator company 20 days after FDA accepted Sandoz’s biosimilar application for review. Amgen alleges Sandoz refuses to comply with statutory obligations and views the obligations as optional, rather than mandatory. Amgen also says that biosimilar applicants have no right to opt out of disclosures required by the BPCIA. In the petition, Amgen lawyers write, “As recent events demonstrate, this Congressionally mandated scheme is at risk of being fundamentally undermined unless FDA acts to ensure that biosimilar applicants make the requisite disclosures. Specifically, at least one biosimilar applicant has chosen to disregard its obligations under subsection (I)(2)(A), and has done so by relying on the belief that the disclosure mandated by subsection (I)(2)(A) is optional.”

Without disclosure of biosimilar application and manufacturing information, Amgen argues that an innovator company may not know a biosimilar has been submitted to FDA and will not be able to identify relevant patents for “meaningful judicial resolution” of patent infringement. Amgen notes that if FDA does not adopt new policies to ensure compliance, “FDA is contributing to that uncertainty to the detriment of the legitimate interests of reference product sponsors, subsequent biosimilar applicants who may wish to seek interchangeability designation, and the public.”