Group asks FDA to mandate biosimilar patent certification

FDA should require that biosimilar applicants provide proof to the agency that they have notified reference product sponsors within 20 days of submitting a biosimilar application, according to a letter from a group of university associations. The timeline is laid out under the biosimilars pathway section of the Patient Protection and Affordable Care Act. However, the group noted that the legislation does not provide for "meaningful consequences" if a biosimilar applicant fails to provide "timely notice and access" to the reference sponsor. As a result, the group said biosimilar sponsors can "effectively circumvent every patent litigation provision" of the biosimilars pathway. The group does not specify how FDA should enforce the notification requirement. The Generic Pharmaceutical Association (GpHA) could not be reached for comment. ...