fda-approval-letter
PHARMACY

Coherus BioSciences gets FDA nod for Neulasta biosimilar

BY Sandra Levy

Coherus BioSciences has received the FDA’s clearance for Udenyca, which is a biosimilar of Amgen’s Neulasta. It is the first pegfilgrastim biosimilar approved by the FDA and the European Commission for patients with cancer receiving myelosuppressive chemotherapy, the company said.

Udenyca is a PEGylated growth colony-stimulating factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

“The list price of Neulasta has nearly tripled since approval in 2002 and now represents a $4 billion annual cost burden in the United States. We believe that competition is essential in controlling burdensome price increases, and Udenyca will play an important role in curbing that spend when launched,” Coherus BioSciences chairman and CEO Denny Lanfear said.“Our in-depth understanding of the market will allow us to deliver significant value to patients, payors and providers in the U.S., including 340 billion hospitals, small clinics and small hospitals.”

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