Big Molecule Watch
November 2, 2018

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 obtain FDA approval under the BPCIA regulatory pathway, and the second FDA-approved biosimilar of Neulasta®, following the FDA’s approval this past June of Mylan and Biocon’s Fulphila® (pegfilgrastim-jmdb), which has since launched.  According to Coherus’ press release, the “company will provide additional details with respect to pricing and launch timing on the November 8 earnings call” reporting financial results for Q3 2018.

As with Neulasta®, the FDA-approved prescribing information for Udenyca states that is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.  In contrast, Neulasta® is additionally indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation.

Coherus and Amgen are currently engaged in U.S. patent litigation in connection with Udenyca.  Earlier this year, the Delaware district court dismissed Amgen’s patent infringement complaint for failing to state a claim upon which relief may be granted because the court found that Amgen was barred under the doctrine of prosecution history estoppel for asserting its infringement claim.  Amgen has appealed the dismissal of its suit to the Federal Circuit, and the parties are in the midst of appellate briefing.

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