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.)

Regulatory

 

Status

Marketed

PDUFA/BSUFA

11/3/2018

  FDA Approval

11/2/18

   
Indications Febrile Neutropenia

Approved (BLA)

   
Efficacy Febrile Neutropenia

Bioequivalence reported in Phase I Trial

 

References:

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. https://www.fda.gov/…/biosimilars/ucm428732.pdf. Accessed: September 26, 2018.

Clinical Trial data obtained at https://clinicaltrials.gov/ct2/home. Accessed: October 29, 2018.

Coherus Biosciences Re-submits Biologics License Application for CHS-1701 (Pegfilgrastim Biosimilar Candidate). Coherus Biosciences. http://investors.coherus.com/news-releases/news-release-details/coherus-biosciences-re-submits-biologics-license-application-chs. 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. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm609805.htm. June 4, 2018.

Five Step Process to Demonstrate Biosimilarity. Coherus Biosciences. https://www.coherus.com/the-frontier-of-biosimilars/five-step-process/. Accessed: October 29, 2018.

Pharma Intelligence Center https://pharma.globaldata.com. 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. 

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