Tagged as: Coherus

FDA Approves Second Pegfilgrastim Biosimilar, a First for Coherus

Today, Coherus BioSciences announced that the U.S. FDA has approved Udenyca™ (pegfilgrastim-cbqv), its biosimilar of Amgen’s Neulasta®, for patients with cancer receiving myelosuppressive chemotherapy.  Udenyca™, which received marketing authorization in Europe in September, is Coherus’ first biosimilar to obtain approval in the United States.  Udenyca™ is the fourteenth biosimilar to…

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FDA accepts Coherus’s resubmitted pegfilgrastim biosimilar application

As we reported earlier this month, Coherus BioSciences recently resubmitted its application for CHS-1701, a proposed biosimilar to Neulasta® (pegfilgrastim), in response to a Complete Response Letter that it received from the FDA last June. Yesterday, Coherus announced that the FDA has accepted its pegfilgrastim resubmission and that the FDA considered…

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Coherus Files Two More Petitions for IPR of Abbvie's '619 Humira Patent

Coherus Biosciences has filed two petitions for inter partes review of Abbvie’s U.S. Patent 9,085,619.  (IPR2017-01008 and IPR2017-01009).  Coherus recently filed four other petitions for inter partes review of the ‘619 patent, as we’ve reported.  Those cases are pending an institution decision. According to the petitions, the ‘619 patent is drawn…

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