RALEIGH, N.C. | July 9, 2026
Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, has announced that the U.S. Food and Drug Administration (FDA) has approved ENNUMO™ (pegfilgrastim-pccg), a biosimilar to NEULASTA® (pegfilgrastim), significantly expanding the company’s oncology supportive care portfolio. The approval marks an important milestone for Accord BioPharma as ENNUMO becomes the company’s second pegfilgrastim biosimilar and further strengthens its position as the only biosimilar manufacturer in the United States offering two pegfilgrastim biosimilars alongside a filgrastim biosimilar. Approved for both adult and pediatric patients, ENNUMO is indicated to reduce the incidence of febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy and to increase survival following hematopoietic subsyndrome of acute radiation syndrome. The approval reinforces Accord BioPharma’s long-term commitment to improving access to high-quality, affordable biologic medicines while supporting healthcare providers with a comprehensive range of granulocyte colony-stimulating factor (G-CSF) biosimilars for oncology care.
FDA Approval Expands Comprehensive G-CSF Biosimilar Portfolio
The approval of ENNUMO™ establishes Accord BioPharma as the only company in the U.S. offering two distinct pegfilgrastim biosimilars—ENNUMO and UDENYCA®—together with FILKRI™, its short-acting filgrastim biosimilar approved earlier in 2026. This expanded G-CSF biosimilar portfolio provides physicians, hospitals, infusion centers, and oncology clinics with multiple treatment options to support patients undergoing chemotherapy who are at risk of chemotherapy-induced febrile neutropenia, one of the most serious complications associated with cancer treatment.
Granulocyte colony-stimulating factors play a critical role in reducing infections, minimizing chemotherapy delays, decreasing hospitalizations, and improving treatment continuity. By expanding its biosimilar offerings, Accord BioPharma aims to improve patient access while addressing the diverse clinical and operational needs of oncology practices through reliable, cost-effective biologic alternatives that maintain the same approved indications as the reference product.
Strategic Biosimilar Expansion Strengthens Oncology Leadership
Advertisement
The latest FDA approval represents another major step in Accord BioPharma’s ambitious biosimilar growth strategy. Backed by Intas Pharmaceuticals, one of the world’s leading biosimilar developers, the company continues expanding its commercial portfolio across oncology, immunology, and central nervous system (CNS) therapies. Accord BioPharma has established a strategic objective of launching 20 biosimilar products in the United States by 2030, positioning itself among the industry’s fastest-growing biosimilar providers.
The company already markets multiple FDA-approved biologics across oncology and immunology, supporting healthcare systems with affordable treatment alternatives while promoting wider patient access to complex biologic medicines. The approval of ENNUMO further demonstrates the strength of its biosimilar development pipeline and reinforces its commitment to addressing growing demand for sustainable biologic therapies that reduce healthcare costs without compromising quality, efficacy, or safety.
Advancing Affordable Oncology Care Through Biosimilar Innovation
The introduction of ENNUMO™ further highlights the increasing importance of biosimilars in modern oncology practice. As cancer incidence continues to rise globally, expanding access to effective supportive care therapies remains essential for improving patient outcomes and maintaining uninterrupted chemotherapy treatment schedules.
By broadening its G-CSF biosimilar portfolio, Accord BioPharma strengthens its ability to support clinicians with multiple treatment options tailored to individual patient needs while contributing to more sustainable healthcare delivery. The FDA approval also underscores the company’s growing expertise in developing and commercializing complex biologic medicines through rigorous scientific development and regulatory excellence. With continued investments in biosimilar innovation and a rapidly expanding commercial pipeline, Accord BioPharma remains focused on accelerating patient access to high-quality biologic therapies, supporting oncology providers, and advancing the future of affordable cancer care through scientifically validated biosimilar medicines that improve both clinical outcomes and healthcare accessibility.
Source: Accord BioPharma press release
