Coherus BioSciences: Udenyca Supply Issue Risks Patient Access

Nearly a year after Coherus BioSciences faced setbacks with their Udenyca syringes due to external manufacturing problems, the California-based pharmaceutical company is once again encountering issues with a third-party manufacturer. Coherus recently disclosed in a securities filing that the Neulasta biosimilar will experience a "temporary" supply interruption because of "overcommitment and capacity constraints" at the U.S. contractor responsible for Udenyca's final packaging. They forecast a notable reduction in Udenyca's supply by mid-October, though they expect production to resume around that same time.

Coherus anticipates that the drug supply will gradually normalize starting in early November. The company emphasized that the supply issues are solely related to labeling and packaging, and do not pertain to the availability or supply of Udenyca's active pharmaceutical ingredients. They also confirmed that there are no production issues with the biosimilar or its finished ingredients. Udenyca, developed as a biosimilar to Amgen's Neulasta, is designed to reduce the risk of infection in patients undergoing treatment with bone marrow suppressive cancer drugs.

To manage the current problem, Coherus is working with contract manufacturers and collaborating with wholesalers and prescribing physicians to mitigate any potential impact from the supply shortage. The company has implemented expedited shipping measures to deliver Udenyca to customers "as soon as possible after the supply is restored." Additionally, Coherus has advanced plans initiated earlier this year to improve its packaging capabilities by engaging another production specialist. This second contract manufacturing organization (CMO) is expected to begin contributing to the research and development of U.WS1882 by the end of 2024, with commercial supply anticipated in the first quarter of 2025.

Regarding the contractor implicated in the supply disruption, Coherus noted that they have worked with their partners for the final packaging of multiple products for more than a decade without any prior incidents or disruptions. However, the company has faced challenges with third-party manufacturers before. Last September, Coherus disclosed that the FDA had rejected Udenyca's human syringe demonstration due to inspection issues with the drug's third-party fillers. It is important to note that the FDA did not raise any concerns regarding the manufacturing of the product, its clinical efficacy, or safety. By late December, Coherus received approval for Udenyca's human syringes. The drug is also available in the form of auto-injectors and pre-filled syringes.

In summary, Coherus BioSciences is currently managing a supply interruption for its Neulasta biosimilar, Udenyca, caused by capacity constraints at a third-party packaging contractor. Despite this, the company expects the supply to resume around mid-October and normalize by early November. Coherus is taking steps to ensure minimal disruption by implementing expedited shipping and enhancing packaging capabilities with an additional production specialist. This supply issue is limited to the packaging process and does not affect the availability or quality of Udenyca's active ingredients.