Coherus Biosciences Addresses Temporary UDENYCA Supply Interruption

Temporary Supply Interruption:
Coherus Biosciences is managing a temporary supply interruption of its UDENYCA product lines due to capacity constraints at its third-party Contract Manufacturing Organization (CMO) for final packaging.

Supply Depletion and Resumption:
The company expects channel supply to be substantially depleted by mid-October, with manufacturing resuming in mid-October and product availability beginning to resume by early November.

Supply Chain Investments:
Coherus has invested over $30 million since 2021 to diversify and enhance its supply chain, including doubling drug substance capacity and expanding drug product fill manufacturing, which is expected to reduce UDENYCA production costs by about one-third.

Strategic Efforts:
The company is accelerating its existing plans to strengthen, diversify, and supplement its final packaging capabilities, including engaging an additional CMO for final packaging and labeling, with commercial supply from this new CMO expected to commence in the first quarter of 2025.

UDENYCA Product Information:
UDENYCA is a biosimilar to Neulasta (pegfilgrastim), used to help reduce the chance of infection due to a low white blood cell count in people with certain types of cancer.