FDA Accepts BLA Resubmission of OBI Presentation of Pegfilgrastim-cbqv

• Coherus, the drug’s manufacturer, resubmitted its biologics license application (BLA) for its on-body injector (OBI) presentation of pegfilgrastim-cbqv (Udenyca OnBody).
• The FDA issued a complete response letter (CRL) in September 2023 due to a review of a third-party filler.
• The FDA approved the pegfilgrastim-cbqv autoinjector presentation in March 2023.

The BLA for the OBI presentation of pegfilgrastim-cbqv has been resubmitted to the FDA. The resubmission follows the FDA’s completion of its inspection of a third-party filler.

The FDA issued a CRL on September 21, 2023, because of an ongoing review of inspection findings at the third-party filler. The CRL did not identify any issues with pegfilgrastim-cbqv’s efficacy, safety, trial design, labeling, or manufacturing. Moreover, the FDA has not requested any additional data or trials from Coherus, the manufacturer.

“We are pleased that resolution of the FDA’s inspection findings has enabled our rapid resubmission of the [Udenyca OnBody] BLA supplement,” said Theresa LaVallee, chief development officer of Coherus, said in a press release.

“We are all focused on bringing this excellent product to patients as quickly as possible,” said Rich Hameister, chief technical officer of Coherus, in a press release.¹

The OBI delivery system that this BLA seeks approval for would eliminate the need for a patient to return to the hospital the day after chemotherapy. Pegfilgrastim (Neulasta) On-Pro is currently the only FDA-approved OBI presentation of pegfilgrastim or a biosimilar.

Pelfilgrastim-cbqv is administered given the day after chemotherapy to decrease the incidence of chemotherapy-associated febrile neutropenia.1 The risk of febrile neutropenia is statistically equivalent between patients receiving pegfilgrastim or a biosimilar of pegfilgrastim.²

The FDA approved pegfilgrastim-cbqv in March 2023 in its single-dose prefilled autoinjector presentation. The original version launched in the US in January 2019.

Other pegfilgrastim biosimilars include pegfilgrastim-pbbk (Fylnetra), pefilgrastim-jmdb (Fulphila), pegfilgrastim-apgf (Nyvepria), and pegfilgrastim-bmez (Ziextenzo). These biosimilars are available by prefilled injection.³

REFERENCES:

1. Coherus announces resubmission of biologics license application (BLA) supplement for Udenyca Onbody. Coherus Biosciences. News release. October 5, 2023. Accessed October 6, 2023. https://tinyurl.com/4rv8p62h

2. Wang CY, Vouri SM, Park H, Heldermon CD, Brown JD. Comparative effectiveness of pegfilgrastim biosimilars vs originator for prevention of febrile neutropenia: A retrospective cohort study. 2023;29(2):119-127. doi:https://doi.org/10.18553/jmcp.2023.29.2.119

3. Pegfilgrastim injection. National Library of Medicine. Updated May 15, 2023. Accessed October 6, 2023. https://medlineplus.gov/druginfo/meds/a607058.html