FDA Issues CRL for Pegfilgrastim-cbqv On-Body Injector Presentation

The FDA approved pegfilgrastim-cbqv with a prefilled autoinjector presentation for the purpose of managing chemotherapy-related febrile neutropenia among patients with cancer in March 2023.

The FDA issued a complete response letter (CRL) to a supplemental biologics license application for an on-body injector (OBI) presentation of pegfilgrastim-cbqv (Udenyca Onbody), a pegfilgrastim (Neulasta) biosimilar, following an inspection at a third-party filler, according to a press release from Coherus BioSciences.¹

The regulatory agency did not highlight any concerns with the pegfilgrastim biosimilar’s safety, clinical efficacy, trial design, labeling, or manufacturing. Additionally, the agency did not request any additional data or trials in support of the biosimilar.

According to the press release, developers have stated their intention to work with the FDA and the third-party filler to ensure that patients with cancer have access to treatment with the pegfilgrastim-cbqv OBI as soon as possible.

The FDA approved pegfilgrastim-cbqv with a prefilled autoinjector presentation for the purpose of managing chemotherapy-related febrile neutropenia among patients with cancer in March 2023.² Developers designed the autoinjector for ease of use in both at-home and in-office treatment settings. The autoinjector’s approval was based on findings included in a comprehensive analytical data package, as well as results from a study concerning its pharmacokinetics, pharmacodynamics, and immunogenicity.

“The introduction of the autoinjector option for [pegfilgrastim-cbqv], with the ability to be administered at home or in the doctor’s office, will provide increased choice and control for patients and physicians, ultimately making treatment more accessible to patients,” Lee Schwartzberg, MD, chief of Medical Oncology and Hematology at the Renown Health William N. Pennington Cancer Institute, and professor of Clinical Medicine at the University of Nevada, said in a press release at the time of the FDA approval.²

Pegfilgrastim-cbqv, a leukocyte growth factor, is indicated for reducing the rate of infection resulting from febrile neutropenia in patients with non-myeloid malignancies treated with myelosuppressive anti-cancer agents. Additionally, the pegfilgrastim biosimilar is designed to potentially benefit survival in patients with acute exposure to myelosuppressive radiation doses. A press release cautions that the agent is not indicated for mobilizing peripheral blood progenitor cells to carry out hematopoietic stem cell transplantation.²

Investigators previously reported findings from a study assessing the pharmacokinetics and pharmacodynamics of the pegfilgrastim-cbqv OBI in October 2021.³ Data highlighted that the pegfilgrastim-cbqv OBI reached all pharmacokinetic primary end points, as well as the secondary pharmacodynamic end point of absolute neutrophil count compared with a pegfilgrastim-cbqv pre-filled syringe formulation. Additionally, investigators identified no new safety signals.

“With our OBI program progress, we are excited by the potential to offer to providers and patients a new on-body injector presentation of [pegfilgrastim-cbqv], if approved.” Denny Lanfear, chief executive officer at Coherus, said in a press release.³

As part of the open-label, randomized crossover study, 189 patients were randomly assigned to receive the pegfilgrastim-cbqv OBI followed by the pre-filled syringe formation, or the reverse. Patients underwent a treatment interval of 6 to 8 weeks.

References

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 26, 2023. https://shorturl.at/nAGR6
2. FDA approves UDENYCA® autoinjector. News release. FDA. Coherus BioSciences, Inc. March 6, 2023. Accessed September 26, 2023. https://bit.ly/3mvalYM
3. Coherus announces positive results of UDENYCA® on-body injector clinical trial. News release. Coherus Biosciences, Inc. October 5, 2021. Accessed September 26, 2023. https://shorturl.at/uBNZ0