Coherus BioSciences (NASDAQ:CHRS) shares gained more than 20% in early trade on Wednesday after it revealed that the United States Food and Drug Administration (FDA) has approved UDENYCA ONBODY, the company's on-body injector presentation of UDENYCA (pegfilgrastim-cbqv).
Pegfilgrastim or biosimilar drugs are administered to cancer patients the day after they complete chemotherapy to decrease the risk of infection.
The company’s UDENYCA ONBODY includes an indicator and status light and auditory signal that allows patients to confirm their drug dose has been administered and a strong and well-tolerated adhesive. Following injection, the needle automatically retracts to reduce the risk of needlestick injury.
Coherus said that it expects the UDENYCA ONBODY will be commercially available in the first quarter of 2024.
“The on-body injector for UDENYCA is the result of years of significant investment in research and development to bring forward a novel and proprietary device that provides patients with an automatic delivery option for their medication,” Coherus CEO Denny Lanfear said in a statement.
“Cancer patients and their physicians will now be able to choose the UDENYCA administration presentation that best fits their individual needs: a prefilled syringe, our autoinjector, or this on-body injector.”
Coherus chief commercial officer Paul Reider added: “We expect that UDENYCA ONBODY’s five-minute injection time and innovative retractable needle mechanism will be well received by cancer patients, their caregivers, and doctors.”
Coherus shares were up 20.2% at US$2.61 on Wednesday morning.