FDA Issues CRL to BLA for On-Body Injector Presentation of Pegfilgrastim-cbqv


The FDA has issued a complete response letter to the biologics license application seeking the approval of the on-body injector presentation of pegfilgrastim-cbqv, which is a biosimilar of pegfilgrastim.



The FDA has issued a complete response letter (CRL) to the biologics license application (BLA) seeking the approval of the on-body injector (OBI) presentation of pegfilgrastim-cbqv (Udenyca OnBody), which is a biosimilar of pegfilgrastim (Neulasta).1

The reason for the letter was due to an ongoing review of inspection findings at a third-party filler, according to an announcement from Coherus BioSciences, Inc. Moreover, the regulatory agency did not identify any issues regarding the efficacy, safety, trial design, labeling, drug substance manufacturing, or device design or manufacturing associated with the biosimilar.

No additional findings or clinical trials have been requested.

“Coherus is committed to working closely with the FDA and the third-party filler to bring Udenyca OnBody to cancer patients requiring pegfilgrastim treatment as quickly as possible,” according to the press release.

Previously, in March 2023, the FDA approved a single-dose prefilled autoinjector presentation of pegfilgrastim-cbqvto be given the day after chemotherapy to reduce the incidence of infection as manifested by febrile neutropenia.2 The regulatory decision was supported by information included in a comprehensive analytical data package as well as a study that examined the pharmacokinetics, pharmacodynamics, and immunogenicity of the product.

Safety data for 932 patients who received pegfilgrastim spanning 7 randomized clinical trials were evaluated.3 In a double-blind, placebo-controlled study, patients with metastatic or non-metastatic breast cancer who were receiving docetaxel at 100 mg/m2 every 21 days (n = 928) were randomly assigned to receive pegfilgrastim at 6 mg (n = 467) or placebo (n = 461).

These patients ranged in age, from 21 years to 88 years; most (99%) were female and Caucasian (66%). The most common toxicities reported in 5% or more of patients that had a between-group difference of at least 5% higher in the pegfilgrastim arm vs placebo were bone pain (31% vs 26%) and pain in the extremity (4% vs 9%). Leukocytosis was reported in less than 1% of the 932 total patients with non-myeloid malignancies who were given pegfilgrastim.

An open-label, crossover study enrolled 189 patients who were randomly assigned 1:1 to receive 1 of 2 treatment sequences of the biosimilar: pegfilgrastim-cbqv administered via the OBI device followed by prefilled syringe administration, or the reverse, with a treatment interval of 6 to 8 weeks.4 In October 2021, Coherus announced that the trial met all pharmacokinetic bioequivalence primary end points and an important pharmacodynamic secondary end point of absolute neutrophil count. No new safety signals were reported.

“Udenyca quickly became the top-selling prefilled syringe pegfilgrastim in the United States within months of launch in 2019, establishing Coherus as a trusted partner to oncologists and demonstrating the power of biosimilar competition to expand patient access to an important cancer medicine,” Denny Lanfear, chief executive officer of Coherus, stated in a press release issued at the time. “With our OBI program progress, we are excited by the potential to offer to providers and patients a new OBI presentation of Udenyca, if approved, and to compete directly with Neulasta Onpro, which retains more than 50% share of the overall pegfilgrastim market.”

If approved, the OBI presentation offers an alternative to the on-body delivery system and removes the need for patients to return to a hospital or other clinical setting the day after chemotherapy to receive the agent.


  1. FDA issues complete response letter (CRL) for Udenyca OnBody biologics license application solely due to an ongoing review of inspection findings at a third-party filler; Coherus also announces completion of toripalimab FDA inspections. News release. Coherus Biosciences, Inc. September 25, 2023. Accessed September 25, 2023. https://investors.coherus.com/news-releases/news-release-details/fda-issues-complete-response-letter-crl-udenycar-onbodytm
  2. FDA approves Udenyca autoinjector. News release. Coherus Biosciences, Inc. March 6, 2023. Accessed September 25, 2023. https://investors.coherus.com/news-releases/news-release-details/fda-approves-udenycar-autoinjector
  3. Udenyca (pegfilgrastim-cbqv). Prescribing information; Coherus Biosciences, Inc. Updated March 2023. Accessed September 25, 2023. https://udenyca.com/hcp/wp-content/pdfs/udenyca-pi.pdf
  4. Coherus announces positive results of Udenyca on-body injector clinical trial. News release. Coherus Biosciences, Inc. October 5, 2021. Accessed September 25, 2023. https://investors.coherus.com/news-releases/news-release-details/coherus-announces-positive-results-udenycar-body-injector

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