Supplies of Coherus Biosciences’ biosimilar version of the white blood cell-stimulating drug Neulasta will be “substantially depleted” through mid-October because of production constraints at a US-based contract manufacturer, the company disclosed Friday.
Without naming the manufacturer, Coherus said in an SEC filing its partner has “over-commitments and capacity constraints” at its labeling and packaging factory. The filing emphasized that there are no issues with the actual drug manufacturing or active pharmaceutical ingredient supply.
New manufacturing of the biosimilar, called Udenyca, will begin again in mid-October and supply will ease by early November, said California-based Coherus, which develops biosimilar drugs in addition to pursuing innovative cancer medicines.
The drugs are used in cancer treatment when patients receive chemotherapy, which depletes their bone marrow and its ability to produce new, infection-fighting white blood cells.
Coherus said it has worked with the unnamed third-party manufacturer for over 10 years and has never faced supply interruptions before. To ease the bottleneck, it’s tapped another labeling and packaging contractor that’s expected to start producing supply at the end of the year to get the drug to markets in the first quarter of 2025.
Coherus has faced issues with third parties before. Last September, the FDA rejected its biologics license application for Udenyca due to issues found at an unnamed manufacturer’s facility.