Coherus BioSciences announced it has resubmitted the Biologics License Application (BLA) Supplement for UDENYCA® ONBODY™, biosimilar to Amgen’s Neulasta® (pegfilgrastim) to the FDA, following a satisfactory resolution of inspection findings at a third-party filler. The resubmission comes after addressing the sole issue identified in the FDA’s Complete Response Letter it received on 21 September 2023.
On 4 October 2023, Coherus announced its sales of Cimerli® (ranibizumab), biosimilar to Genentech’s Lucentis® surpassed 100,000 doses in its first year.