FDA Denies Request To Make "Patent Dance" A Prerequisite For Biosimilar Approval

In a decision released on March 25, 2015, FDA denied a Citizen's Petition that would have effectively made the information and patent exchange described in § 262 of the Biologics Price Competition and Innovation Act ("BPCIA") a precondition for approval. The Petition, which had been filed by Amgen, requested that FDA require biosimilar applicants to certify to FDA that they had provided the reference product sponsor a copy of their biosimilar application as well as "information that describes the process(es) used to manufacture the biosimilar product that is the subject of that application." FDA Response at 1. FDA denied the Petition, finding that the language of the BPCIA did not require FDA to act and explaining that that FDA would not exercise its discretion to force biosimilar applicants to comply with a provision the interpretation of which is currently the subject of ongoing litigation.