FDA Approves Coherus' Pegfilgrastim Biosimilar, Udenyca

After previous US regulatory setbacks, Coherus Biosciences has gained FDA approval for its pegfilgrastim biosimilar, Udenyca (pegfilgrastim-cbqv).

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.

The company was hit hard by the CRL, terminating 30% of its workforce in a bid to shave $10 million from its operating costs as it worked to meet the FDA’s requests. Having completed its reanalysis of the immunogenicity assay—and having raised new funds through a private placement deal with Temasek—Coherus resubmitted its BLA in May 2018.

While Coherus worked toward resubmission, it also won a key legal battle in its bid to bring its biosimilar to market; in March 2018, a Delaware court judge granted Coherus’ motion to dismiss a lawsuit brought by Amgen over alleged infringement of US patent 8,273,707 (which covers the reference Neulasta), helping to clear the way for the product to launch in the United States.

Udenyca joins 1 other pegfilgrastim biosimilar in the ranks of United States approvals; Mylan's Fulphila is also approved, and launched, in the US market.