Pegfilgrastim-cbqv (Udenyca™) – 2018 FDA Approval

FDA Approval: 11/2/18

Febrile neutropenia is a complication that can occur in cancer patients receiving chemotherapy. Normally, neutrophils (a type of white blood cell) protect against infections; however, chemotherapy treatments may cause a reduction in neutrophils to abnormal levels in cancer patients, known as neutropenia. When significant neutropenia occurs in the presence of a fever, it is referred to as febrile neutropenia.

Coherus BioScience’s pegfilgrastim-cbqv (UDENYCA™) is a biosimilar of pegfilgrastim (Neulasta®), a long-acting version of Amgen’s Neupogen(R) (filgrastim). UDENYCA™ is a long-acting granulocyte colony-stimulating factor (G-CSF) developed to decrease the chance of infection associated with febrile neutropenia, in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy with a significant incidence of febrile neutropenia.

The first pegfilgrastim biosimilar, Fulphila™ (pegfilgrastim-jmdb), developed by Mylan and Biocon, was approved by the FDA on June 4, 2018. UDENYCA™, approved on November 2, 2018, will be the second pegfilgrastim biosimilar on the market in the U.S.

For our complete review of pegfilgrastim-cbqv (UDENYCA™):

Executive Summary of Evaluation:


Pegfilgrastim-cbqv / UDENYCA™

(Coherus BioSciences Inc.)







  FDA Approval


Indications Febrile Neutropenia

Approved (BLA)

Efficacy Febrile Neutropenia

Bioequivalence reported in Phase I Trial



Aapro M, Boccia R, Leonard R, Camps C, Campone M, et al. Refining the role of pegfilgrastim (a long-acting G-CSF) for prevention of chemotherapy-induced febrile neutropenia: consensus guidance recommendations. Support Care Cancer (2017) 25:3295–3304.

Christl, Leah. FDA’s Overview of the Regulatory Guidance for the Development and Approval of Biosimilar Products in the US. U.S. Food and Drug Administration.…/biosimilars/ucm428732.pdf. Accessed: September 26, 2018.

Clinical Trial data obtained at Accessed: October 29, 2018.

Coherus Biosciences Re-submits Biologics License Application for CHS-1701 (Pegfilgrastim Biosimilar Candidate). Coherus Biosciences. May 3, 2018.

FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment. U.S. Food and Drug Administration. June 4, 2018.

Five Step Process to Demonstrate Biosimilarity. Coherus Biosciences. Accessed: October 29, 2018.

Pharma Intelligence Center Accessed: July 30, 2018.

Rasmy A, Amal A, Fotih S, Selwi W (2016). Febrile Neutropenia in Cancer Patient: Epidemiology, Microbiology, Pathophysiology and Management. J Cancer Prev Curr Res 5(3): 00165.


Additional 2018 Pipeline Reviews are available in our pipeline library.

Please see the most recent FDA Actions Newsletter for additional information on recent FDA approvals


Coauthored by: Kristen Ciampi, PharmD

Kristen recently graduated with a PharmD degree from the University of Rhode Island in May of 2018, and is a Pharmacy Analytics Intern at RJ Health Systems.