A federal court in California has ruled that under the Biologics Price Competition and Innovation Act ("BPCI Act") a biosimilar applicant is not required to provide its application to the reference product sponsor. Rather, the order states the applicant may comply if it wants to take advantage of the safe harbor from declaratory judgment actions for patent infringement provided in the BPCI Act. The court also ruled that there is no bar to market entry for the biosimilar at issue, Zarxio, which recently became the first biosimilar approved by FDA.
A separate but recently filed action between another reference product sponsor and biosimilar applicant raising similar issues is currently pending in federal court in Massachusetts.
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