
FDA Denies Amgen's Certification Petition in Biosimilar Patent Dance
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
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
Sources:
FDA
Momenta
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