Coherus BioSciences Faces Digital Dilemma: Udenyca Supply Disruption Threatens Patient Access to Treatment

Nearly a year after Coherus BioSciences' Udenyca syringes were rejected due to external manufacturing issues, a third-party manufacturer is once again troubling the California-based pharmaceutical company. Coherus revealed in a recent securities filing that the Neulasta biosimilar would face a "temporary" supply disruption due to "overcommitment and capacity constraints" faced by the U.S. contractor responsible for Udenyca's final packaging. Coherus warned that the supply of Udenyca could be "significantly reduced" by mid-October, although it expects production of the biosimilar to resume around the same time.

Accordingly, Coherus's drug supply should gradually resume starting in early November. Coherus stressed that the tight supply is only related to labeling and packaging, not the availability or supply of Udenyca's active pharmaceutical ingredients. The company added that there were no problems with the production of the biosimilar and the finished ingredients themselves. Udenyca was developed in reference to Amgen's best-selling bone marrow stimulator, Neulasta, to reduce the risk of infection in certain patients who are being treated with bone marrow suppressive cancer drugs. In addition to working with contract manufacturers to address the current issue, Coherus said it will work with wholesalers and prescribing physicians to mitigate any potential impact the supply shortage may have.

First, Coherus has put in place expedited shipping measures to get Udenyca to customers "as soon as possible after supply is restored." In addition, the company has accelerated plans since earlier this year to enhance its packaging capabilities by recruiting another production specialist. Coherus said the second CMO is expected to begin participating in the research and development of U.WS1882 by the end of 2024, with commercial supply expected to enter the market in the first quarter of 2025. Regarding the contractor behind the supply crunch, Coherus noted that it has been working with partners for final packaging of multiple products for more than a decade without any incidents or disruptions. Still, third-party manufacturers have caused Coherus problems in the past.

Last September, the company revealed that the FDA had rejected Udenyca's human syringe demonstration due to inspection issues with the drug's third-party fillers. However, the FDA did not raise any concerns about the manufacturing of the product, its clinical efficacy or safety. In late December, Coherus finally received Udenya's approval for human syringes. The drug is also marketed in the form of auto-injectors and pre-filled syringes.