Accord BioPharma Launches FILKRI Biosimilar in U.S

RALEIGH, N.C., Oct. 12, 2026 /CourierPR/ -- Accord BioPharma, a division of Intas Pharmaceuticals, has launched its biosimilar, FILKRI (filgrastim-laha), in the United States. Approved by the FDA in January 2026, FILKRI is the company's latest addition to its oncology supportive care portfolio, aiming to bring a total of 20 biosimilars to the U.S. market by 2030.

FILKRI is indicated for several medical conditions, including decreasing the incidence of infection, particularly febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs. It is also used to reduce the time to neutrophil recovery and the duration of fever following chemotherapy in patients with acute myeloid leukemia. Additionally, FILKRI can reduce the duration of neutropenia and its related clinical sequelae, such as febrile neutropenia, in patients undergoing myeloablative chemotherapy followed by bone marrow transplantation. It is also indicated for managing neutropenia in patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia, and for increasing survival in patients acutely exposed to myelosuppressive doses of radiation.

The biosimilar is available in two prefilled syringe presentations: 300 mcg/0.5 mL and 480 mcg/0.8 mL, with pack sizes of one or 10 prefilled syringes per carton. Accord BioPharma has been assigned a permanent Q-code (Q5172) by the U.S. Centers for Medicare & Medicaid Services, effective October 1, 2026, which will standardize the billing and reimbursement process across all sites of care.

FILKRI joins Accord BioPharma's existing G-CSF portfolio, which includes UDENYCA (pegfilgrastim-cbqv), offering both short- and long-acting treatment options. This expanded portfolio aims to meet the individual needs of patients undergoing chemotherapy and their healthcare providers.

The filgrastim biosimilar market has seen significant growth, accounting for approximately 77% of the filgrastim market share as of the fourth quarter of 2025. Accord BioPharma is committed to expanding access through competitive pricing and patient support programs, such as AccordCares, which provides comprehensive patient resources, including benefits investigation and co-pay assistance.

FILKRI is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors (G-CSFs) such as filgrastim or pegfilgrastim products. Additionally, the drug is associated with potential side effects, including splenic rupture, acute respiratory distress syndrome, and serious allergic reactions. Patients should be monitored for signs of these conditions, and appropriate treatment should be administered if necessary.

In conclusion, the launch of FILKRI marks a significant step in Accord BioPharma's mission to bring innovative biosimilars to the U.S. market, enhancing patient care and access to essential treatments.