Pharma To Date

Coherus BioSciences has announced a temporary supply interruption for its Neulasta biosimilar, Udenyca, due to production constraints at a third-party contractor. This disruption arises from “over-commitments and capacity constraints” experienced by the U.S.-based manufacturer responsible for the final packaging of Udenyca. As a result, Coherus anticipates that supplies will be “substantially depleted” by mid-October.

The company has clarified that the issue is confined to packaging and labeling, with no impact on the active pharmaceutical ingredient or the core manufacturing processes. Coherus projects that production will resume around the same time as the depletion, with a gradual replenishment of supplies expected to begin in early November. In response, Coherus is implementing several measures to mitigate the disruption's effects on patients and healthcare providers.

To address the supply gap, Coherus is collaborating with wholesalers and prescribers to manage potential disruptions. Expedited shipping plans have been put in place to ensure that Udenyca reaches customers as quickly as possible once supply levels normalize. Additionally, the company is advancing its efforts to enhance packaging capabilities by bringing on a second contract manufacturer, expected to contribute to Udenyca’s production by the end of 2024. This new addition aims to stabilize the supply chain and ensure that commercial availability resumes in the first quarter of 2025.

This supply interruption is noteworthy for healthcare professionals managing patients on Udenyca, as it highlights the broader issue of supply chain vulnerabilities in the pharmaceutical industry. The proactive measures taken by Coherus underscore the importance of maintaining robust supply chain practices to prevent disruptions in the availability of essential medications. The resolution of this issue is crucial for ensuring continued access to effective treatments for patients undergoing myelosuppressive chemotherapy, who rely on Udenyca to reduce the risk of infection.