FDA Issues CRL to BLA of OBI Presentation of Pegfilgrastim-cbqv

• The FDA issued a complete response letter (CRL) for a biosimilar of pegfilgrastim (Neulasta) due to ongoing inspections at a third-party filler.

• The FDA did not request further trials, and Coherus BioSciences will collaborate with the FDA and the filler to expedite the availability of the product for patients needing pegfilgrastim.

• An on-body injector presentation may replace the need for post-chemotherapy hospital visits.

A complete response letter (CRL) has been issued by the FDA to the biologics license application (BLA) seeking the approval of a biosimilar of pegfilgrastim (Neulasta), the on-body injector (OBI) presentation of pegfilgrastim-cbqv (Udenyca OnBody), according to Coherus BioSciences, Inc.¹

The reason for the CRL is due to an ongoing review of inspection findings at a third-party filler. No issues regarding the efficacy, safety, trial design, labeling, drug substance manufacturing, device design, or manufacturing associated with the biosimilar were identified by the FDA.

No additional findings or clinical trials have been requested by the regulatory agency, and the company will continue to work closely with the FDA and the third-party filler to bring Udenyca OnBody to patients with cancer who require pegfilgrastim as quickly as possible.

Pegfilgrastim-cbqv is a prefilled autoinjector given to patients the day after chemotherapy as a single dose with a triggered push-on-skin activation. The agent works to decrease the incidence of infection from febrile neutropenia associated with patients with non-myeloid malignancies who are receiving anti-cancer myelosuppressive therapy.²

In a prior randomized, open-label, crossover study, investigators sought to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence of pegfilgrastim-cbqv administered via a proprietary OBI device compared with the currently marketed version as a pre-filled syringe in 189 patients. Findings of the study showed that all the PK bioequivalence primary endpoints were met. Further, the key secondary endpoint of absolute neutrophil count was achieved.

In March 2023, the FDA granted approval to a single-dose prefilled autoinjector presentation of pegfilgrastim-cbqvto(Udencya) that is given the day after chemotherapy to decrease the incidence of chemotherapy-associated febrile neutropenia in patients with cancer.³ Information from a comprehensive analytical data package and pharmacokinetic, pharmacodynamic, and immunogenicity study supported this approval. This approval allows pegfilgrastim to be offered in 2 on-demand options, as a prefilled syringe and as an autoinjector, each of which may allow for more flexibility when treating patients.

According to a press release, an OBI presentation of pegfilgrastim-cbqv would offer an alternative to the originator’s on-body pegfilgrastim delivery system. This would also eliminate the need for patients to return to a hospital or other clinical setting the day after chemotherapy to receive pegfilgrastim-cbqv.⁴

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 25, 2023. https://tinyurl.com/5pzkh9x8

2. Udenyca (pegfilgrastim-cbqv). Prescribing information; Coherus Biosciences, Inc. Updated March 2023. Accessed September 25, 2023. https://tinyurl.com/2eaumn7z

3. FDA approves Udenyca autoinjector. News release. Coherus Biosciences, Inc. March 6, 2023. Accessed September 25, 2023. https://tinyurl.com/2533pjay

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://tinyurl.com/ybyt8cbk