Coherus Biosciences has sought to develop an on-body injector formulation of its pegfilgrastim biosimilar Udenyca® that can provide long-awaited competition to Amgen’s Neulasta OnPro.
The company suffered a setback when the FDA issued a complete response letter in September, not accepting its supplemental biologic licensing application (BLA). The BLA was rejected because of inspection issues at a third-party supplier, and it was not related to the product’s efficacy or safety or its manufacture.
Coherus announced in early October that it had resubmitted its supplemental BLA for the Udenyca on-body injector, an unusually rapid turnaround for a pharmaceutical company. A new FDA decision date has not yet been announced.
Coherus could use this win, and soon, as its stock price has fallen about 70% in 2023, to a low of $2.66 on October 26. According to the Samsung Bioepis Biosimilar Market Report for Q3 2023, Udenyca has roughly a 22% share of the pegfilgrastim injectable market, but Amgen’s Biosimilar Trend Report indicated in October 2022 that Neulasta OnPro continues to hold the greatest share (45%) of the overall category. Coherus hopes that its own pegfilgrastim on-body injector will significantly improve Udenyca marketshare and revenues.
In Other Biosimilar News
Amneal announced an extension to its marketing agreement with mAbxience, in which Amneal will commercialize two denosumab biosimilars presently in development. These two denosumab agents will compete with Prolia® (indicated to prevent osteoporosis) and Xgeva® (indicated to treat several forms of metastatic cancer that have spread to the bone). Amneal and mAbxience have an existing partnership for Alymsys®.