FDA Approves ENNUMO™ (pegfilgrastim-pccg), Accord BioPharma's Second Pegfilgrastim Biosimilar to NEULASTA® (pegfilgrastim)
Approval gives Accord BioPharma the most comprehensive granulocyte colony-stimulating factor (G-CSF) biosimilar portfolio in the U.S., with two pegfilgrastim options and a filgrastim
RALEIGH, N.C., July 9, 2026 /PRNewswire/ -- Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and central nervous system (CNS) therapies, announced today that the U.S. Food and Drug Administration (FDA) has approved ENNUMO™ (pegfilgrastim-pccg), a biosimilar to NEULASTA® (pegfilgrastim). ENNUMO is indicated in adults and pediatric patients aged newborn and older to decrease 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 to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).1 ENNUMO is approved by the FDA for the same indications as its reference product, NEULASTA.
With this approval, Accord BioPharma is now the only company in the U.S. offering two distinct pegfilgrastim biosimilars — ENNUMO and UDENYCA® (pegfilgrastim-cbqv) — alongside FILKRI™ (filgrastim-laha), its short-acting granulocyte colony-stimulating factor (G-CSF) biosimilar approved in February 2026. Together, these three products form a G-CSF portfolio designed to meet the diverse clinical and operational needs of oncology practices, hospitals, and the patients they serve.
"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 portfolio in the world from a single biosimilar company. We are on track to deliver 20 biosimilars by 2030. We recognize that both patients and oncology practices are counting on us for the long term as we expand our oncology product offerings. Most importantly we are proud that we have and will continue to increase patient access to these critically important medicines."
Expanding Access Through Portfolio Breadth
Febrile neutropenia is 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.2 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 across a range of clinical settings.
"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. "With ENNUMO and UDENYCA, we have pegfilgrastim biosimilar options to offer—alongside FILKRI for short-acting G-CSF—so we can meet physicians and their patients where they are."
Part of a Broader Biosimilar Growth Story
The approval of ENNUMO marks the latest milestone in Accord BioPharma's rapid portfolio expansion. The company has set a strategic goal to launch 20 biosimilar products in the U.S. by 2030, building on a growing commercial portfolio that now spans oncology and immunology, with an aim to further expand into central nervous system therapies. Backed by Intas Pharmaceuticals, Ltd., one of the world's largest and most experienced biosimilar developers with nearly five decades of global pharmaceutical expertise, Accord BioPharma is uniquely positioned to deliver on this ambition.
"ENNUMO's approval is another proof point that what we're building at Accord BioPharma can genuinely change the treatment landscape for patients in the U.S.," said Binish Chudgar, Chairman and Managing Director, Intas Pharmaceuticals, 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."
Contact: [email protected]
IMPORTANT SAFETY INFORMATION
Contraindications: ENNUMO is contraindicated in patients with a history of a serious hypersensitivity reaction to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis.
Splenic Rupture: Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products. Patients who report left upper abdominal or shoulder pain after receiving ENNUMO should be evaluated for an enlarged spleen or splenic rupture.
Acute Respiratory Distress Syndrome: Acute respiratory distress syndrome (ARDS) can occur in patients receiving pegfilgrastim products. Evaluate patients for ARDS who develop fever, lung infiltrates or respiratory distress after receiving ENNUMO. Discontinue ENNUMO in patients with ARDS.
Serious Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products. The majority of reported events occurred upon initial exposure and can recur within days after the discontinuation of initial therapies to manage the reaction. Permanently discontinue ENNUMO in patients with serious hypersensitivity reactions.
Use in Patients with Sickle Cell Disorders: Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastim products. Discontinue ENNUMO if sickle cell crisis occurs.
Glomerulonephritis: Glomerulonephritis has occurred in patients receiving pegfilgrastim products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation of pegfilgrastim products. If glomerulonephritis is suspected, evaluate for cause and if likely, consider dose-reduction or interruption of ENNUMO.
Leukocytosis: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during ENNUMO therapy is recommended.
Thrombocytopenia: Pegfilgrastim products can cause thrombocytopenia. Monitor platelet counts during ENNUMO therapy.
Capillary Leak Syndrome: Capillary leak syndrome has been reported after granulocyte colony-stimulating factor (G-CSF) administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Closely monitor patients who develop symptoms of capillary leak syndrome and provide standard symptomatic treatment, which may include a need for intensive care.
Potential for Tumor Growth Stimulatory Effects on Malignant Cells: The G-CSF receptor through which pegfilgrastim products and filgrastim products act has been found on tumor cell lines. The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer: MDS and AML have been associated with the use of pegfilgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.
Aortitis: Aortitis has been reported in patients receiving pegfilgrastim products and may occur as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue ENNUMO if aortitis is suspected.
Nuclear Imaging: Increased hematopoietic activity of the bone marrow in response to growth factor therapy, including pegfilgrastim products, has been associated with transient positive bone imaging changes and should be considered when interpreting bone imaging results.
Most Common Adverse Reactions:
Most common adverse reactions (≥ 5% higher difference in incidence compared to placebo) are bone pain and pain in extremity.
INDICATIONS
ENNUMO is a leukocyte growth factor indicated in adults and pediatric patients aged newborn and older to:
- Decrease 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.
- Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
Limitations of Use:
ENNUMO is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
ENNUMO (pegfilgrastim-pccg) injection for manual use is supplied in a 6 mg/0.6 mL single-dose prefilled syringe.
Click here for full Prescribing Information.
NEULASTA® (pegfilgrastim) is a registered trademark of Amgen Inc.
About Accord BioPharma
Accord BioPharma, Inc. is the U.S. specialty division of Intas Pharmaceuticals, Ltd., one of the world's most experienced biosimilar developers. Focused on the therapeutic areas of oncology, immunology, and CNS, Accord BioPharma is committed to expanding patient access to high-quality, affordable biologic therapies. The company's FDA-approved commercial portfolio includes UDENYCA® (pegfilgrastim-cbqv) – a biosimilar to NEULASTA® (pegfilgrastim); FILKRI™ (filgrastim-laha) – a biosimilar to NEUPOGEN® (filgrastim); IMULDOSA® (ustekinumab-srlf) – a biosimilar to STELARA® (ustekinumab); HERCESSI™ (trastuzumab-strf) – a biosimilar to HERCEPTIN® (trastuzumab); and CAMCEVI® (leuprolide mesylate) injectable emulsion. Accord BioPharma has received FDA approval on additional products including OSVYRTI® (denosumab-desu) – a biosimilar to Prolia® (denosumab), JUBEREQ® (denosumab-desu) – a biosimilar to Xgeva® (denosumab), IMMGOLIS™ (golimumab-sldi) – a biosimilar to Simponi® (golimumab), and IMMGOLIS INTRI™ (golimumab-sldi) – a biosimilar to Simponi Aria® (golimumab). The company's strategic goal is to launch 20 biosimilar products in the U.S. by 2030. For more information, visit www.accordbiopharma.com.
References
- ENNUMO™ (pegfilgrastim-pccg) Prescribing Information. Accord BioPharma.
- Tai E, Guy GP, Dunbar A, Richardson LC. Cost of cancer-related neutropenia or fever hospitalizations, United States, 2012. J Oncol Pract. 2017;13(6):e552-e561.
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SOURCE Accord BioPharma
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