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FDA Approves On-Body Administration of Neulasta Biosimilar


The Food and Drug Administration approved Udenyca Onbody, an administration device for Udenyca, a biosimilar of Neulasta.

FDA Approval

The Food and Drug Administration (FDA) approved Udenyca Onbody, an injector for Udenyca (pegfilgrastim-cbqv) that attaches to the patient’s body, according to a press release issued by Coherus BioSciences, the manufacturer of the device.

Udenyca is a biosimilar of Neulasta (pegfigrastim), which is a drug given the day after chemotherapy that works to prevent infections by stimulating the bone marrow to make white blood cells.

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

READ MORE:FDA Approves Neulasta 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 Udenyca, does not have any clinically meaningful differences to the reference product (Neulasta).

“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 five-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 (how the drug interacts with the body) and pharmacodynamic (how the drug works within the body) 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 three administration options for Udenyca: a prefilled syringe, an autoinjector and Udenyca Onbody.

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