Accord BioPharma Secures FDA Approval for FILKRI™ (filgrastim-laha), Biosimilar to NEUPOGEN®
Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., has announced a significant milestone: the U.S. Food and Drug Administration (FDA) has approved FILKRI™ (filgrastim-laha). This product is a biosimilar to the established reference product, NEUPOGEN® (filgrastim). The approval, announced on February 17, 2026, bolsters Accord BioPharma’s commitment to developing and delivering critical care, immunology, and oncology therapies in the U.S. market.
Expanding the Supportive Care Arsenal
The approval of FILKRI marks the sixth FDA-approved biosimilar for Accord BioPharma and the seventh approved product overall within their burgeoning portfolio. This expansion is strategic, particularly following Accord BioPharma’s acquisition last year of UDENYCA® (pegfilgrastim-cbqv), a biosimilar counterpart to Neulasta® (pegfilgrastim). With the addition of FILKRI, Accord BioPharma now offers healthcare providers a complete granulocyte colony-stimulating factor (G-CSF) portfolio, featuring both short-acting (FILKRI) and long-acting (UDENYCA) biosimilar options.
FILKRI is indicated for several critical patient populations:
- Patients with cancer receiving myelosuppressive chemotherapy.
- Patients with acute myeloid leukemia receiving induction or consolidation chemotherapy.
- Patients with cancer undergoing bone marrow transplantation.
- Patients with severe chronic neutropenia.
- Patients acutely exposed to myelosuppressive doses of radiation (addressing the hematopoietic syndrome of acute radiation syndrome).
Chrys Kokino, President of Accord North America, emphasized the clinical significance: “Cancer patients often face significant challenges with treatment-related neutropenia, which can lead to serious infections, treatment delays, and dose reductions that may compromise therapeutic outcomes. With FILKRI alongside UDENYCA, the provider-preferred option over Neulasta and all other biosimilars, we now offer healthcare providers a complete G-CSF portfolio with short- and long-acting biosimilar options. This positions Accord BioPharma as a committed partner in oncology supportive care, expanding access to high-quality biologics.”
Addressing Neutropenia: The Role of G-CSF
Neutropenia, the reduction of neutrophils—the body’s primary defense against bacterial and fungal infections—is a frequent and potentially severe consequence of cancer treatment. G-CSF growth factors, like filgrastim, stimulate the bone marrow to produce and release these vital neutrophils, thereby accelerating recovery and reducing the risk and duration of severe infections.
FILKRI, manufactured using recombinant DNA technology, functions by precisely regulating neutrophil production within the bone marrow. Demonstrating its biosimilar status, FILKRI’s approval was predicated on extensive data from two randomized studies in healthy adults, which confirmed its similarity to NEUPOGEN in pharmacokinetics (PK) and pharmacodynamics (PD) parameters, as well as comparable safety and immunogenicity profiles.
Streamlining Access and Reimbursement
To ensure seamless integration into the healthcare system, Accord has initiated the process for obtaining a permanent Q-code from the U.S. Centers for Medicare & Medicaid Services (CMS). This code is essential for standardizing billing and facilitating reimbursement across various settings, including hospital outpatient departments, ambulatory surgery centers, and physician offices.
Accord BioPharma’s Vision for Biosimilars
This launch underscores Accord BioPharma’s overarching commitment to biosimilars as a transformative force in treatment accessibility. Supported by Intas Pharmaceuticals’ extensive global experience, the company aims to rapidly expand its U.S. presence. The strategic goal is the launch of 20 biosimilar products by 2030, cementing its role as a dependable supplier of high-quality, cost-effective biologic alternatives.
Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals, stated, “This approval of FILKRI demonstrates our steadfast dedication to expanding access to cost-effective biologic treatments in the critically important field of oncology. We’re proud to have one of the largest biosimilar pipelines within the industry. With Accord BioPharma, we’re positioning ourselves as a dependable partner in the United States—one that’s deeply committed to understanding stakeholder priorities and revolutionizing patient access.”
Current and Upcoming Portfolio Highlights
Beyond FILKRI, Accord BioPharma maintains a robust commercial presence, including the full UDENYCA franchise (prefilled syringe, autoinjector, and on-body injector). The company also markets IMULDOSA® (ustekinumab-srlf), HERCESSI™ (trastuzumab-strf), and CAMCEVI® (leuprolide) 42 mg injectable emulsion.
Furthermore, Accord has received FDA approval for three additional products slated for commercial launch later this year: CAMCEVI® (leuprolide) ETM (every three months), OSVYRTI® (denosumab-desu), and JUBEREQ® (denosumab-desu), biosimilars to PROLIA® and XGEVA®, respectively. Patients and providers are advised to consult the full Prescribing Information and Important Safety Information for all marketed products.