A week after a federal court in California ruled that the patent information exchange provisions of the Biologics Price Competition and Innovation Act ("BPCIA") are not mandatory, FDA has denied the reference product manufacturer's citizen petition for FDA to require biosimilar applicants to certify they will participate in those provisions. FDA determined the certification procedures are separate from the biosimilar application review process by the agency and stated the courts should decide the scope and parameters of that process under the statute.

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