Nearly a year after Coherus BioSciences’ on-body injector for Udenyca was rejected over external production issues, a third-party manufacturer has caused another spot of bother for the California-based drugmaker.
Thanks to “over-commitments and capacity constraints” facing the U.S.-based contractor in charge of final packaging for Udenyca, the Neulasta biosimilar will suffer a “temporary” supply interruption, Coherus said in a securities filing late last week.
Coherus warned that Udenyca supplies are likely to be “substantially depleted” by the middle of October, though the company expects production of the biosimilar will rev back up around the same time. In turn, supplies of Coherus’ drug should gradually become available again starting in early November.
Coherus stressed that the supply squeeze is solely related to labeling and packaging and does not concern the availability or supply of Udenyca’s active pharmaceutical ingredient. Manufacturing of the biosimilar product and finished product components themselves are also not at issue, the company added.
Udenyca, which references Amgen’s blockbuster bone marrow stimulant Neulasta, was approved in November 2018 to decrease the incidence of infection in certain patients who are receiving myelosuppressive anti-cancer drugs.
Aside from working with its contract manufacturer to address the issue, Coherus said last week that it will also team up with wholesalers and prescribers to ease any potential disruptions caused by the supply deficit.
For one, Coherus has locked in expedited shipping measures to get Udenyca to customers “as quickly as possible when supply resumes.”
In addition, the company is speeding up plans from earlier this year to supplement its packaging capabilities through the enlistment of another production specialist. That second CMO is expected to start pitching in on Udenyca manufacturing by the end of 2024, with commercial supply expected to hit the market in 2025’s first quarter, Coherus said.
As for the contractor behind the supply squeeze, Coherus noted that it has worked with the partner for final packaging of multiple products over the span of more than a decade without any prior incident or interruption.
Still, third-party manufacturers have caused issues for Coherus in the past.
Last September, the company revealed that the FDA snubbed an on-body injector presentation of Udenyca, citing inspection problems at a third-party filler for the drug. The agency didn’t raise any concerns about the drug substance or device manufacturing for the product, nor its clinical efficacy or safety.
Coherus ultimately snared approval for Udenyca’s on-body injector in late December. The medication is also sold in an autoinjector and as a prefilled syringe.