Developers Resubmit BLA for Pegfilgrastim On-Body Injector Presentation

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A biologic license application supplement resubmission for the pegfilgrastim-cbqv on-body injector follows the resolution of inspection findings highlighted in a complete response letter from the FDA.

Developers Resubmit BLA for Pegfilgrastim On-Body Injector Presentation | Image Credit: © VanHope - stock.adobe.com.

Pegfilgrastim-cbqv received FDA approval with a single-dose, prefilled autoinjector presentation to mitigate the risk of infection resulting from febrile neutropenia among patients receiving chemotherapy for cancer in March 2023.

The FDA has received a resubmitted biologics license application (BLA) supplement for an on-body injector (OBI) presentation of pegfilgrastim-cbqv (Udenyca Onbody), a pegfilgrastim (Neulasta) biosimilar, according to a press release from Coherus Biosciences.1

Developers resubmitted the BLA supplement after resolving concerns highlighted in the FDA’s inspection findings at a third-party filler as highlighted in a complete response letter (CRL) for the pegfilgrastim-cbqv injector in September 2023.2 The regulatory agency did not discern any problems related to the pegfilgrastim-cbqv OBI’s efficacy or tolerability, labelling, trial design, drug substance manufacturing, or device design. Additionally, no other clinical trial data were requested to the support the biosimilar.

“We are pleased that resolution of the FDA’s inspection findings has enabled our rapid resubmission of the [pegfilgrastim-cbqv injector’s] BLA supplement,” Theresa LaVallee, chief development officer at Coherus, said in the press release.1 “As the CRL identified no other issues with the BLA supplement, we look forward to working closely with the agency to complete the review of the [pegfilgrastim-cbqv injector] application in a timely manner and anticipate potential approval later this year.”

Pegfilgrastim-cbqv received FDA approval with a single-dose, prefilled autoinjector presentation to mitigate the risk of infection resulting from febrile neutropenia among patients receiving chemotherapy for cancer in March 2023.3 Support for the autoinjector’s approval came from a comprehensive analytical data package plus findings from a study affirming its pharmacodynamics, pharmacokinetics, and immunogenicity.

“There are certain types of patients [with cancer], those who live far away, have an active lifestyle, or who are supporting the needs of a busy family, for whom this option eliminates the need to return to the clinic and enables them to choose the time and place for treatment without having to wear an on-body device,” 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.3

Previously, investigators highlighted positive findings from an open-label, randomized trial supporting the bioequivalence of the pegfilgrastim-cbqv OBI presentation and a pre-filled syringe formulation in October 2021.4 The OBI formulation met all primary end points concerning pharmacokinetic bioequivalence, as well as the secondary end point of absolute neutrophil count compared with the pre-filled syringe formulation. Moreover, the pegfilgrastim-cbqv OBI did not raise any new safety signals.

A total of 189 patients in the trial were randomly assigned to receive the pegfilgrastim-cbqv OBI followed by the pre-filled syringe formation, or the reverse. Study treatment continued for 6 to 8 weeks.

“Coherus appreciates the great collaboration with our third-party manufacturer and the swift and comprehensive actions taken to address the inspectional issues raised by the [FDA]. We are all focused on bringing this excellent product to patients as quickly as possible,” Rich Hameister, Chief Technical Officer at Coherus, concluded.1

References

  1. Coherus announces resubmission of biologics license application (BLA) supplement for UDENYCA® ONBODY™. News release. Coherus Biosciences, Inc. October 5, 2023. Accessed October 6, 2023. https://bit.ly/48Jzjar
  2. 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 October 6, 2023. https://shorturl.at/nAGR6
  3. FDA approves UDENYCA® autoinjector. News release. FDA. Coherus BioSciences, Inc. March 6, 2023. Accessed October 6, 2023. https://bit.ly/3mvalYM
  4. Coherus announces positive results of UDENYCA® on-body injector clinical trial. News release. Coherus Biosciences, Inc. October 5, 2021. Accessed October 6, 2023. https://shorturl.at/uBNZ0
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