On February 17, 2026 Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, reported that the U.S. Food and Drug Administration (FDA) has approved FILKRI (filgrastim-laha), a biosimilar to NEUPOGEN (filgrastim), for 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; and patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome).1

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The approval of FILKRI marks the sixth product in Accord BioPharma’s growing portfolio of FDA-approved biosimilars, following the company’s acquisition last year of UDENYCA (pegfilgrastim-cbqv), a biosimilar to Neulasta (pegfilgrastim),2 as well as the seventh approved product in the overall portfolio. With the addition of FILKRI, Accord BioPharma now offers physicians in the U.S. a comprehensive granulocyte colony-stimulating factor (G-CSF) portfolio with both long-acting (UDENYCA) and short-acting (FILKRI) biosimilar options to meet the needs of patients, providers, and practices.1,2

Accord has applied for and expects to receive a permanent Q-code from the U.S. Centers for Medicare & Medicaid Services (CMS), which will standardize and facilitate the billing and reimbursement process across hospital outpatient, ambulatory surgery center, and physician office settings of care.

Tackling Vital Healthcare Needs
Neutropenia is a common and potentially serious complication of cancer treatment and occurs when white blood cells called neutrophils—which serve as a major line of defense against bacterial and fungal infections—fall below normal levels. This reduction increases a person’s risk of developing an infection. Granulocyte colony-stimulating factor, or G-CSF, is a growth factor that stimulates the production and release of neutrophils in the body. By accelerating neutrophil recovery, G-CSF can help reduce the duration of neutropenia.3,4

FILKRI belongs to the G-CSF class and is a growth factor manufactured by recombinant DNA technology. FILKRI works by regulating the production of neutrophils within the bone marrow.1

"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," said Chrys Kokino, President, Accord North America. "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."

Demonstrated Biosimilarity and Safety Profile
FILKRI was approved based on two randomized studies in healthy adults, with pharmacokinetics (PK)/pharmacodynamics (PD) assessed in one study and safety and immunogenicity evaluated in both, compared with reference product NEUPOGEN. These studies demonstrated the biosimilarity in PD and PK parameters between FILKRI and NEUPOGEN and showed overall safety and immunogenicity similar to NEUPOGEN.5 FILKRI is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors, such as filgrastim products or pegfilgrastim products.1

Expanding Access: Accord BioPharma’s Biosimilar Vision
Accord BioPharma believes deeply in the power of biosimilars to reshape the future of treatment. With the support of Intas, an established global leader with nearly five decades of experience, Accord BioPharma is transforming the conventional treatment landscape across several priority therapeutic areas by introducing biosimilars to the U.S. market.

As part of this commitment, Accord BioPharma is rapidly expanding its U.S. portfolio with a strategic goal to launch 20 biosimilar products by 2030, solidifying its position as a reliable partner delivering more affordable, high-quality biologic alternatives. In addition to developing and marketing their own biosimilar products, the company is strategically collaborating with select partners around the world to bring more biosimilars to the U.S. market as swiftly as possible.

"This approval of FILKRI demonstrates our steadfast dedication to expanding access to cost-effective biologic treatments in the critically important field of oncology," said Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals. "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."

(Press release, Accord BioPharma, FEB 17, 2026, View Source [SID1234662732])