FDA Approves Onbody Administration System for Pegfigrastim Biosimilar


The Food and Drug Administration approved an on-body delivery system for pegfilgrastim-cbqv, a biosimilar of pegfilgrastim.

FDA Approves Onbody Administration System for Pegfigrastim Biosimilar

FDA Approves Onbody Administration System for Pegfigrastim Biosimilar

The Food and Drug Administration (FDA) approved an on-body injecting system for pegfilgrastim-cbqv (Udenyca) — a biosimilar of pegfigrastim (Neulasta), which is administered the day after chemotherapy to prevent infections — according to a press release issued by Coherus BioSciences, the manufacturer of the device.

Udenyca was approved in November 2018 to decrease infection, as manifested by febrile neutropenia, in patients undergoing myelosuppressive chemotherapy. Of note, myelosuppressive chemotherapy is associated with a clinically significant increase in febrile neutropenia.

READ MORE: FDA Approves Pegfilgrastim Biosimilar to Decrease Incidence of Infection

A biosimilar is a medication that, according to the FDA, is, “highly similar to a biological medication already approved by the FDA — the original biologic (also called the reference product.” Notably, clinical trials must prove that the biosimilar, such as pegfilgrastim-cbqv, does not have any clinically meaningful differences to the reference product (pegfigrastim). Now, pegfilgrastim-cbqv can be administered via Udenyca Onbody.

“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,” Denny Lanfear, CEO of Coherus, said in the press release.

Udenyca Onbody is worn directly on the patient’s body and injects Udenyca into the patient. After the drug is administered, the needle automatically retracts, which, according to the release, can reduce the risk of injury from the needle. The device also has an indicator and status light, as well as an auditory signal that helps patients confirm that Udenyca has been administered.

“We expect that Udenyca Onbody’s 5-minute injection time and innovative retractable needle mechanism will be well received by cancer patients, their caregivers and doctors,” said Paul Reider, Coherus’ chief commercial officer.

The FDA’s approval of the device is based on an analytical and clinical data package that outlined the pharmacokinetic and pharmacodynamic bioequivalence. According to the release, Udenyca Onbody also has sufficient adhesive performance and tolerability data.

According to Coherus’ statement, it is expected that Udenyca Onbody will become available to patients within the first quarter (January through March) of 2024. With the approval of the onbody device, there are now 3 administration options for Udenyca: a prefilled syringe, an autoinjector, and Udenyca Onbody.

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