With filler issue resolved, Coherus eyes on-body pegfilgrastim launch

Coherus says approval of its on-body injector version of biosimilar Udenyca is likely by early 2024 following the resolution of a production deficiency at a third-party manufacturer.

Coherus BioSciences won US Food and Drug Administration (FDA) for Udenyca, a biosimilar of Amgen’s Neulasta (pegfilgrastim), in November 2018.

An attempt to commercialize an on-body injector version of the biosimilar – Udenyca ONBODY – hit a roadblock in September, when the FDA issued a Complete Response Letter (CRL) due to an ongoing review of inspection findings at a third-party filler.

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But speaking on the firm’s Q3 2023 financial call this week, chief development officer Theresa LaVallee said the undisclosed contract development and manufacturing organization (CDMO) has resolved the issue “with urgency” and a resubmission to the FDA has been made.

“It is important to note the only deficiency in the CRL from FDA was the third-party manufacturer indicating that clinical and manufacturing data were complete,” she said. “Given there isn’t any new information for FDA to review, we anticipate approval this year or in the early part of 2024 and anxiously await the resource-constrained FDA to take action.”

For the quarter, Udenyca net sales stood at $33 million, an increase of 4% quarter-over-quarter, while market share grew to 16.5%. Amgen, meanwhile, reported Neulasta sales of $124 million for the period worldwide, down 50% on the same period 2022.

According to chief commercial officer Paul Reider “demand and market share gains were driven primarily from our core prefilled syringe presentation and occurred across all segments of the business.”

The quarter saw the launch of an auto-injector version of Udenyca and a further positive development through increased payor coverage. “Udenyca is now a franchise,” he told stakeholders, adding this will only grow larger through the addition of the on-body version.

“Following the anticipated approval, Udenyca on-body injector will be the only pegfilgrastim brand to three presentations offerings, becoming the total solution for oncology providers. This will enable us to compete directly with Neulasta Onpro, which retains 42% of the market.”