New Delivery Device for Udenyca
A wearable dose form of Udenyca® (pegfilgrastim-cbqv), Coherus BioSciences’ biosimilar for Neulasta® (pegfilgrastim – Amgen), was FDA approved on Dec 22, 2023. Theleukocyte growth factor is indicated for lowering the chances of infections for patients who receive cancer drugs that interfere with the bone marrow’s production of blood cells and that are associated with a clinically significant incidence of febrile neutropenia, an adverse effect of some chemo. It also is approved to raise the likelihood of surviving Hematopoietic Subsyndrome of Acute Radiation Syndrome, a result of exposure to radiation high enough or long enough to depress bone marrow activity. For cancer patients, it is given as one 6mg subcutaneous (SC) injection no later than 24 hours following each round of chemo and no sooner than two weeks before the next chemo is scheduled. The new Udenyca Onbody™ is only recommended for adult patients receiving chemo, not for patients being treated for radiation exposure. It is attached with an adhesive to the patient’s abdomen or upper arm after a healthcare professional fills it with a single dose of the drug, typically when the patient is in a facility for receiving chemo. The device is preprogrammed to administer Udenyca automatically over five minutes at the appropriate time. After the drug has been delivered, the device should be discarded in a sharps container, not in the general trash. Before and during use, Udenyca Onbody should be kept at least four inches away from cell phones, microwave ovens, and other electronics. Although Neulasta also has a wearable form (Neulasta® Onpro®), none of its other biosimilars has been FDA-approved for a similar device. Udenyca, which is available in single-dose prefilled syringes and auto-injector pens, is not interchangeable with Neulasta or any of the other pegfilgrastim biosimilars that also are marketed in the U.S. Coherus plans to introduce Udenyca Onbody in the first quarter of 2024, but it has not yet revealed cost information. Prescribing information, which includes detailed directions for using the Onbody device, is here.