Udenyca FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 17, 2024.
FDA Approved: Yes (First approved November 2, 2018)
Brand name: Udenyca
Generic name: pegfilgrastim-cbqv
Dosage form: Injection
Company: Coherus BioSciences, Inc.
Treatment for: Neutropenia Associated with Chemotherapy, Neutropenia Associated with Radiation
Udenyca (pegfilgrastim-cbqv) is a PEGylated growth colony-stimulating factor biosimilar to Neulasta (pegfilgrastim) indicated to reduce the duration of febrile neutropenia in patients treated with chemotherapy and to increase survival in patients acutely exposed to myelosuppressive doses of radiation.
- Udenyca is indicated to:
- decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
- increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). - Udenyca was approved as a biosimilar based on data demonstrating that it is highly similar to the FDA-approved biological reference product containing pegfilgrastim, and that there are no clinically meaningful differences between the biosimilar product and the reference product.
- Udenyca is administered via subcutaneous injection once per chemotherapy cycle for patients receiving chemotherapy, and as two doses one week apart for patients acutely exposed to myelosuppressive doses of radiation.
- Udenyca injection is supplied as:
- a single-dose pre-filled syringe 6 mg/0.6 mL
- a single-dose prefilled autoinjector 6 mg/0.6 mL
- a single-dose prefilled syringe co-packaged with the on-body injector (Udenyca Onbody) 6 mg/0.6 mL - Warnings and precautions associated with Udenyca include splenic rupture; acute respiratory distress syndrome; serious allergic reactions; sickle cell crises; glomerulonephritis; thrombocytopenia; and increased risk of myelodysplastic syndrome and/or acute myeloid leukemia in patients with breast and lung cancer who receive Udenyca in conjunction with chemotherapy and/or radiation therapy.
- Common adverse reactions include bone pain and pain in extremities.
- Udenyca is the second FDA-approved pegfilgrastim biosimilar, after the approval of Fulphila (pegfilgrastim-jmdb) in 2018.
Development timeline for Udenyca
Further information
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