FDA Approves Pegfilgrastim Biosimilar for Febrile Neutropenia

The FDA has approved pegfilgrastim-pccg (Ennumo), a biosimilar to Neulasta (pegfilgrastim), for adult and pediatric patients, according to an announcement from Accord BioPharma¹

Pegfilgrastim-pccg carries the same indications as its reference product: reducing the incidence of infection as manifested by febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia, and increasing survival in patients acutely exposed to myelosuppressive doses of radiation for Hematopoietic Subsyndrome of Acute Radiation Syndrome.¹

The FDA's approval was supported by a comprehensive comparability exercise that established pegfilgrastim-pccg is highly similar to Neulasta, with no clinically meaningful differences in purity, potency, or safety.² The product was developed using technology transferred from South Korea's SunBio, which supplies the polyethylene glycol derivative used in manufacturing. Pegfilgrastim-pccg is supplied as a 6 mg/0.6 mL single-dose prefilled syringe for manual use.¹

Notably, pegfilgrastim-pccg has not been granted interchangeability status by the FDA, meaning pharmacists cannot substitute it for Neulasta without prescriber authorization.² The approval makes pegfilgrastim-pccg the eighth pegfilgrastim biosimilar approved in the US, entering a market that has seen intensifying pricing competition since the first pegfilgrastim biosimilar was approved in 2018.²

The most commonly reported adverse reactions with pegfilgrastim products occurring at an incidence at least 5% greater than placebo are bone pain and pain in the extremities.¹ The prescribing information for pegfilgrastim-pccg carries warnings and precautions for splenic rupture (including fatal cases), acute respiratory distress syndrome, serious hypersensitivity reactions including anaphylaxis, severe sickle cell crises in patients with sickle cell disorders, glomerulonephritis, leukocytosis, thrombocytopenia, capillary leak syndrome, and aortitis. Pegfilgrastim-pccg is contraindicated in patients with a history of serious hypersensitivity to pegfilgrastim or filgrastim products.¹

Biosimilar approvals for pegfilgrastim products have relied on totality-of-evidence packages comprising structural and physicochemical characterization, functional assays, pharmacokinetic and pharmacodynamic comparability studies, and clinical safety and immunogenicity data.² Approval of pegfilgrastim-pccg followed this established framework, with the comparability exercise confirming structural fidelity and biological activity consistent with the reference product.²

The approval pathway is consistent with that used for other approved pegfilgrastim biosimilars, which have relied on pharmacokinetic and pharmacodynamic studies in healthy volunteers and cancer patients to establish bioequivalence, typically achieving geometric mean ratios within prespecified equivalence margins for area under the curve, maximum concentration, maximum absolute neutrophil count, and neutrophil count area under the curve.³

Febrile neutropenia is among the most serious and frequent complications of myelosuppressive chemotherapy, contributing to treatment delays, dose reductions, hospitalizations, and increased mortality risk.¹ Granulocyte colony-stimulating factors (G-CSFs) have become a standard component of oncology supportive care, and the expanding biosimilar landscape for these agents has played an important role in broadening access across clinical settings.

With this approval, Accord BioPharma becomes the only company in the US offering two distinct pegfilgrastim biosimilars: pegfilgrastim-pccg and UDENYCA (pegfilgrastim-cbqv), which was first approved in 2018. Together with Filkri (filgrastim-laha), a short-acting G-CSF biosimilar approved in February 2026, the company now holds what it describes as the most comprehensive G-CSF biosimilar portfolio in the US.¹

"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, stated in a news release.¹ "With Ennumo, we now offer healthcare providers the largest G-CSF portfolio in the world from a single biosimilar company.”

References

1. FDA approves pegfilgrastim-pccg, Accord BioPharma's second pegfilgrastim biosimilar to Neulasta (pegfilgrastim). News release. Accord BioPharma. July 9, 2026. Accessed July 9, 2026. https://www.accordbiopharma.com/news/fda-approves-ennumo-pegfilgrastim-pccg-accord-biopharmas-second-pegfilgrastim-biosimilar-to-neulasta-pegfilgrastim/

2. US Food and Drug Administration. Biosimilar product information. Updated July 2026. Accessed July 9, 2026. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information

3. Glaspy JA, Natale RB, Roila F, et al. Pharmacokinetic and pharmacodynamic equivalence of pegfilgrastim-cbqv and pegfilgrastim in healthy subjects. Adv Ther. 2020;37(11):4614-4628. doi:10.1007/s12325-020-01459-y