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FDA Approves Pegfilgrastim Biosimilar to Decrease Incidence of Infection

Monday, November 05, 2018
The Food and Drug Administration (FDA) approved pegfilgrastim-cbqv (Udenyca), a biosimilar to pegfilgrastim (Neulasta).

According to the biosimilar’s manufacturer, Coherus Biosciences, the biosimilar is 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—defined as fever or other signs of infection with a low count of neutrophils, a type of infection-fighting white blood cell.

A biosimilar, which is a biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA, has no clinically meaningful difference in terms of safety, purity, and potency.

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

The company will provide more details on pricing and a launch date on its November 8 earnings call.

A version of this article was originally published by CURE® as "FDA Approves Neulasta Biosimilar to Decrease Incidence of Infection"


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