FDA Approves ENNUMO™ (pegfilgrastim-pccg), Accord BioPharma's Second Pegfilgrastim Biosimilar to Neulasta

The U.S. Food and Drug Administration has approved ENNUMO (pegfilgrastim查看药品详情-pccg), a biosimilar to Amgen查看公司主页's Neulasta (pegfilgrastim), Accord BioPharma (搜索)搜索该词条 announced on July 9, 2026. The approval positions Accord BioPharma as the only company in the U.S. with two distinct pegfilgrastim biosimilars — ENNUMO and UDENYCA (pegfilgrastim-cbqv) — alongside FILKRI (filgrastim查看药品详情-laha), its short-acting G-CSF查看药品详情 biosimilar approved in February 2026.

ENNUMO is indicated in adults and pediatric patients aged newborn and older to decrease the incidence of infection, as manifested by febrile neutropenia (搜索)搜索该疾病, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia, and to increase survival in patients acutely exposed to myelosuppressive doses of radiation for Hematopoietic Subsyndrome of Acute Radiation Syndrome. The biosimilar is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

"Every FDA approval marks a step forward in our mission to expand patient access to high-quality, affordable biologic therapies," said Chrys Kokino, President, Accord North America. "With ENNUMO, we now offer healthcare providers the largest G-CSF查看药品详情 portfolio in the world from a single biosimilar company. We are on track to deliver 20 biosimilars by 2030."

Regulatory Basis and Product Details

The FDA's approval was supported by a comprehensive comparability exercise demonstrating that ENNUMO is highly similar to Neulasta, with no clinically meaningful differences in purity, potency, or safety. The product is supplied as a 6 mg/0.6 mL single-dose prefilled syringe for manual subcutaneous injection. Notably, ENNUMO has not been granted interchangeability status, meaning it cannot be substituted for Neulasta at the pharmacy level without prescriber involvement.

ENNUMO leverages technology transferred from South Korea's SunBio (搜索)搜索该词条, which supplies the high-quality polyethylene glycol derivative essential to the drug's manufacturing process. Under the terms of their agreement, SunBio stands to receive milestone payments tied to this approval and ongoing royalties on U.S. net sales.

Clinical Significance and Safety Profile

Febrile neutropenia (搜索)搜索该疾病 remains one of the most serious and frequently occurring complications of myelosuppressive chemotherapy, contributing to treatment delays, dose reductions, hospitalizations, and increased mortality risk in patients with cancer. Granulocyte colony-stimulating factors have become a cornerstone of oncology supportive care, and biosimilars are playing an increasingly critical role in expanding access to these therapies.

The prescribing information for ENNUMO carries notable warnings, including risks of fatal splenic rupture, acute respiratory distress syndrome, serious hypersensitivity reactions including anaphylaxis, sickle cell crises in patients with sickle cell disorders, glomerulonephritis, capillary leak syndrome, leukocytosis, thrombocytopenia, and aortitis. The most commonly reported adverse reactions, occurring at an incidence at least 5% greater than placebo, are bone pain and pain in extremity.

The label also notes that the G-CSF查看药品详情 receptor has been found on tumor cell lines, and the possibility that pegfilgrastim查看药品详情 products act as a growth factor for any tumor type cannot be excluded. Additionally, myelodysplastic syndrome and acute myeloid leukemia have been associated with pegfilgrastim use in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer.

Portfolio Strategy and Market Context

"From speaking with our customers, we know the needs of oncology practices are not one-size-fits-all, and we've built our portfolio to address this reality," said Nuvan Dassanaike, Senior Vice President, Digital and Marketing Strategy & Operations, Accord BioPharma (搜索)搜索该词条. "With ENNUMO and UDENYCA, we have pegfilgrastim查看药品详情 biosimilar options to offer — alongside FILKRI for short-acting G-CSF查看药品详情 — so we can meet physicians and their patients where they are."

ENNUMO becomes the eighth FDA-approved biosimilar referencing Neulasta, joining Fulphila, Ziextenzo, Nyvepria, Udenyca, Fylnetra, Stimufend, and Armlupeg. Accord has already established a strong presence for pegfilgrastim查看药品详情 biosimilars in Europe, where it was the first to commercialize a biosimilar version and remains the only company offering an autoinjector device. Intas Pharmaceuticals查看公司主页, Accord's parent company, further consolidated its global leadership position in this class with the August 2025 acquisition of Udenyca from Coherus BioSciences.

"ENNUMO's approval is another proof point that what we're building at Accord BioPharma (搜索)搜索该词条 can genuinely change the treatment landscape for patients in the U.S.," said Binish Chudgar, Chairman and Managing Director, Intas Pharmaceuticals查看公司主页, Ltd. "Our goal of 20 biosimilars by 2030 is not just a number. It reflects the depth of our pipeline and our determination to deliver."

Accord BioPharma (搜索)搜索该词条's FDA-approved commercial portfolio now includes UDENYCA, FILKRI, IMULDOSA (ustekinumab-srlf), HERCESSI (trastuzumab-strf), and CAMCEVI (leuprolide mesylate), with additional approvals for OSVYRTI (denosumab-desu), JUBEREQ (denosumab-desu), IMMGOLIS (golimumab-sldi), and IMMGOLIS INTRI (golimumab-sldi). As the pegfilgrastim查看药品详情 biosimilar market becomes increasingly saturated, the entry of ENNUMO is poised to deliver significant cost savings for cancer patients and healthcare systems.