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A federal court in California has ruled that under the Biologics Price Competition and Innovation Act a biosimilar applicant is not required to provide its application to the reference product sponsor.
United StatesFood, Drugs, Healthcare, Life Sciences
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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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Court Rules Biosimilar Patent Procedures Optional, Allows Marketing Of First Biosimilar
United StatesFood, Drugs, Healthcare, Life Sciences
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Jones Day is a global law firm with more than 2,500 lawyers across five continents. The Firm is distinguished by a singular tradition of client service; the mutual commitment to, and the seamless collaboration of, a true partnership; formidable legal talent across multiple disciplines and jurisdictions; and shared professional values that focus on client needs.
