FDA Approves Ennumo, Pegfilgrastim Biosimilar Referencing Neulasta, for Febrile Neutropenia and Radiation Exposure

The FDA approved a pegfilgrastim biosimilar, Ennumo (pegfilgrastim-pccg; Accord BioPharma)—referencing Neulasta (Amgen)—for adults and pediatric patients aged newborns and older to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. Additionally, it is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation (hematopoietic subsyndrome of acute radiation syndrome). Ennumo is approved for the same indications as its reference product, according to a news release.¹

Reference pegfilgrastim is a pegylated granulocyte colony-stimulating factor approved by the FDA to reduce the risk of febrile neutropenia in patients receiving myelosuppressive chemotherapy regimens. Primary prophylactic use is indicated when the patient's risk of febrile neutropenia reaches or exceeds 20%, and no equally effective yet safer alternative chemotherapy regimen is available. In addition to its FDA-approved indications, pegfilgrastim is also used off-label in patients who are undergoing autologous transplantation, but this is only recommended when performed under expert supervision.^1,2

According to the news release, the manufacturer is now the only US company that offers 2 distinct pegfilgrastim biosimilars—Ennumo and Udenyca (pegfilgrastim-cbqv)—to receive approval from the FDA.^1,3

Clinical Trial Data Supporting Ennumo

Pegfilgrastim was evaluated in 4 studies in patients receiving myelosuppressive chemotherapy. Studies 1 and 2 were randomized, double-blind, active-controlled trials in patients with metastatic breast cancer receiving doxorubicin and docetaxel every 21 days for up to 4 cycles. Patients were randomly assigned to receive either a single subcutaneous injection of pegfilgrastim on day 2 of each chemotherapy cycle or daily subcutaneous filgrastim (Neupogen; Amgen) beginning on day 2.⁴

In both studies, pegfilgrastim demonstrated efficacy comparable to filgrastim, with mean days of severe neutropenia in cycle 1 of 1.8 versus 1.6 days in Study 1 and 1.7 versus 1.6 days in Study 2, respectively. Similar results were observed in cycles 2 through 4.⁴

Study 3 was a randomized, double-blind, placebo-controlled trial in 928 patients with metastatic or nonmetastatic breast cancer receiving docetaxel every 21 days for up to 4 cycles. A single subcutaneous injection of pegfilgrastim on day 2 of each cycle significantly reduced febrile neutropenia compared with placebo (1% vs 17%; p < .001), as well as hospitalizations (1% vs 14%) and IV anti-infective use (2% vs 10%) related to febrile neutropenia.⁴

Study 4 was a multicenter, randomized, open-label study in pediatric and young adult patients aged 0 to 21 years with sarcoma receiving myelosuppressive chemotherapy, in which recovery of neutrophil counts was similar between pegfilgrastim and filgrastim.⁴

The prescribing information states that, because efficacy studies of pegfilgrastim products could not be conducted in humans with acute radiation syndrome, approval for this indication was based on animal efficacy studies and data supporting pegfilgrastim’s effect on severe neutropenia in patients with cancer receiving myelosuppressive chemotherapy.⁴

Safety Data for Ennumo

Ennumo’s prescribing information states that the agent’s safety data were based on 7 randomized clinical trials in which 932 patients received pegfilgrastim. The most common adverse events in placebo-controlled clinical trials were bone pain (31% vs 26%) and pain in extremity (9% vs 4%) in the pegfilgrastim and placebo arms, respectively.⁴

"Every FDA approval marks a step forward in our mission to expand patient access to high-quality, affordable biologic therapies," Chrys Kokino, president, Accord North America, said. "With Ennumo, we now offer health care providers the largest G-CSF portfolio in the world from a single biosimilar company. We are on track to deliver 20 biosimilars by 2030. We are proud that we have and will continue to increase patient access to these critically important medicines."¹

REFERENCES

1. FDA Approves ENNUMO™ (pegfilgrastim-pccg), Accord BioPharma's Second Pegfilgrastim Biosimilar to NEULASTA® (pegfilgrastim). PR Newswire. News release. July 9, 2026. Accessed July 9, 2026. https://www.prnewswire.com/news-releases/fda-approves-ennumo-pegfilgrastim-pccg-accord-biopharmas-second-pegfilgrastim-biosimilar-to-neulasta-pegfilgrastim-302821209.html

2. Patel P, King N, Jacobs TF. Pegfilgrastim. StatPearls [Internet]. Updated October 21, 2025. Accessed July 9, 2026. https://www.ncbi.nlm.nih.gov/books/NBK532893/

3. McGovern G. FDA Approves Filkri, Filgrastim Biosimilar Referencing Neupogen for Cancer Treatment–Related Indications. Pharmacy Times. February 17, 2026. Accessed July 9, 2026. https://www.pharmacytimes.com/view/fda-approves-filkri-filgrastim-biosimilar-referencing-neupogen-for-cancer-treatment-related-indications

4. ENNUMO (pegfilgrastim-pccg) injection, for subcutaneous use Initial U.S. Approval: 2026 – Highlights of Prescribing Information. Updated May 2026. Accessed July 9, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761147Orig1s000lbl.pdf