United States:
FDA Denies Petition To Require Biosimilar Applicant To Certify Information Exchange
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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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