ARTICLE
27 April 2015

Court Denies Motion To Delay Launch Of First Approved Biosimilar

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The first U.S. biosimilar product Zarxio overcame another legal challenge earlier this month when a federal court in California denied a motion to enjoin its commercial launch.
United States Food, Drugs, Healthcare, Life Sciences

The first U.S. biosimilar product Zarxio overcame another legal challenge earlier this month when a federal court in California denied a motion to enjoin its commercial launch. The motion was in response to a previous decision in the case, holding that under the patent litigation provisions of the Biologics Price Competition and Innovation Act, the biosimilar applicant was not required to provide its application to the reference product sponsor, a ruling currently on appeal to the Federal Circuit. In a footnote, the judge indicated Zarxio's manufacturer had agreed not to launch the biosimilar product until the earlier of May 11, 2015, or a decision on the pending appeal.

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