FDA Denies Amgen's Certification Petition in Biosimilar Patent Dance

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Biosimilar applicants will not be required to hand over their biosimilar applications and manufacturing dossiers to innovator companies, determines FDA.

In October 2014, Amgen filed a Citizen’s Petition with FDA asking that the agency require biosimilar applicants to comply with the process laid out by the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The company also asked 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. On Mar. 25, 2015, FDA announced they will not require such disclosure. This announcement follows a court ruling earlier in the week that determined that it is not mandatory that a biosimilar sponsor share its biologics license application information with an innovator company. Amgen recently appealed this decision, although Sandoz has agreed not to launch until a ruling from the Federal Circuit on Amgen’s request or May 11, whichever comes first.

The petition denial is based on the interpretation of 351(l) of the Public Health Services (PHS) Act and whether or not the language in said document requires the submittal of certain information about a biosimilar or simply suggests it to avoid patent disputes between a biosimilar applicant and an innovator-drug company. The petition from Amgen said that noncompliance with 351(l)(2)(A) goes against the intentions of Congress, while a rebuttal from Momenta Pharmaceuticals contends that FDA does not have an enforcement role with respect to the “private patent exchange process under Section 351(l)” and that Congress actually intended to separate FDA from the patent resolution process. Momenta also argues that the recommendations regarding application and manufacturing disclosures are suggested for those seeking to resolve potential patent issues prior to commercial launch of a product.

FDA notes that neither 351(k) nor 351(l) sections of the PHS requires FDA to certify the biosimilar review process via an enforced information exchange between parties. This “lack of certification requirement” differs from the process that is required under section 505(b) for applications for small-molecule drugs listed in the Orange Book, which requires that abbreviated new drug application (ANDA) sponsors “identify certain patents for listing by FDA.”


Momenta, a biopharmaceutical company with biosimilars in development, said in a letter that it submitted its comments to FDA "to oppose attempts by some in the industry to transform the Section 351(l) private patent exchange process into an FDA-regulated regime" and argued that "Amgen’s unstated objective is to force all biosimilar applicants to engage in the private patent exchange process and challenge patents under Section 351(l) to deter or delay applicants from seeking regulatory approval under a 351(k) application." In a separate press release, Momenta’s President and CEO, Craig Wheeler, said “We believe the FDA’s denial of this petition is a step in the right direction toward encouraging the use of the 351(k) pathway and promoting an efficient review and approval process for biosimilars.”