FDA Approves Coherus Pegfilgrastim Biosimilar Udencya

Nov 7, 2018 | Biosimilars

The biosimilar, referencing Neulasta, has been approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients receiving myelosuppressive chemotherapy associated with a clinically significant incidence of febrile neutropenia. “We are excited to announce that Coherus has received FDA approval for Udenyca. I want to thank the Coherus team, our strategic partners, and the [FDA] for this extraordinary achievement,” said Denny Lanfear, chairman, CEO and president of Coherus BioSciences. “The list price of Neulasta has nearly tripled since approval in 2002 and now represents a $4 billion annual cost burden in the US. We believe that competition is essential in controlling burdensome price increases, and Udenyca will play an important role in curbing that spend when launched,” he added.  The company will provide more details on pricing and a launch date on its November 8 earnings call.  Udenyca was also authorized for marketing in the European Union in September of this year after having received a positive opinion from the European Medicines Agency’s Committee for Human Use in July 2018.  Today’s news marks a major milestone for Coherus and for Udenyca, which has had a difficult road to approval. After its first filing of a Biologics License Application for the biosimilar, Coherus revealed in June 2017 that the FDA had issued a Complete Response Letter (CRL) for the drug, requesting that the company provide additional manufacturing information as well as a reanalysis of a subset of samples with a revised immunogenicity assay.


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