Raleigh, North Carolina, United States, October 12, 2026
Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., has announced the commercial launch of FILKRI™ (filgrastim-laha) in the United States, expanding its portfolio of biosimilar treatments for oncology supportive care. FILKRI is a biosimilar to NEUPOGEN® (filgrastim), a granulocyte colony-stimulating factor (G-CSF) used to help manage neutropenia and reduce infection-related complications in several clinical settings. The launch gives healthcare professionals access to both short-acting FILKRI and the company’s long-acting biosimilar UDENYCA® (pegfilgrastim-cbqv). Accord said FILKRI is available with a permanent Q-code, Q5172, assigned by the U.S. Centers for Medicare & Medicaid Services (CMS), effective October 1, 2026. The company expects the new product to strengthen its oncology supportive care portfolio while supporting broader access to biosimilar medicines.
FILKRI Expands Neutropenia Treatment Options
FILKRI is indicated for several conditions associated with neutropenia, a reduction in neutrophils, the white blood cells that help the body fight bacterial and fungal infections. Neutropenia can occur following chemotherapy or other treatments that affect bone marrow function, increasing the risk of serious infections and potentially complicating cancer treatment. The medicine is indicated to reduce the incidence of infection manifested as febrile neutropenia in patients with nonmyeloid malignancies receiving certain myelosuppressive anticancer drugs. It is also indicated to shorten neutrophil recovery time and fever duration following induction or consolidation chemotherapy for acute myeloid leukemia. Additional approved uses include reducing neutropenia and related complications following myeloablative chemotherapy and bone marrow transplantation, managing complications associated with severe chronic neutropenia, and increasing survival following acute exposure to myelosuppressive doses of radiation. FILKRI is available in 300 mcg/0.5 mL and 480 mcg/0.8 mL prefilled syringes, supplied in cartons containing one or 10 syringes. The treatment is designed to stimulate neutrophil production and recovery, helping clinicians manage specific risks associated with neutropenia.
Permanent Q-Code Supports Billing and Reimbursement
A key feature of the U.S. launch is FILKRI’s permanent HCPCS Q-code Q5172, which became effective on October 1, 2026. The code is intended to standardize product identification for billing and support reimbursement processes across healthcare settings. Accord BioPharma stated that having the permanent code available at launch could help streamline administrative procedures for physicians and healthcare providers. The company is also offering patient resources through AccordCares®, its patient support program, which includes benefits investigations and copay assistance. These services are intended to help eligible patients understand coverage and navigate access to treatment. Affordability and reimbursement remain important considerations in oncology supportive care, where patients may require additional medicines to manage complications associated with cancer treatment. By combining commercial availability with reimbursement infrastructure and patient support, Accord aims to strengthen access to its biosimilar portfolio. Actual coverage, patient eligibility and out-of-pocket costs will depend on individual insurance arrangements and applicable program requirements.
Advertisement
Biosimilar Strategy Strengthens Oncology Portfolio
FILKRI’s launch advances Accord BioPharma’s strategy to expand its presence in the U.S. biosimilar market. The company is part of Intas Pharmaceuticals and focuses on specialty medicines across oncology, immunology and central nervous system conditions. With FILKRI and UDENYCA, Accord offers short-acting and long-acting G-CSF biosimilar options, allowing healthcare professionals to consider different treatment approaches based on clinical needs and prescribing information. According to the company, FDA approval of FILKRI was supported by evidence demonstrating high similarity to the reference product, NEUPOGEN, with no clinically meaningful differences. Biosimilars are developed to demonstrate similarity to an already approved biological medicine and can offer additional treatment options. However, FILKRI is not interchangeable with its reference product solely because it is a biosimilar; prescribing and substitution decisions must follow applicable regulatory requirements. Accord has also stated its strategic goal of bringing 20 biosimilar products to the U.S. market by 2030. The FILKRI launch represents another step toward that objective and reinforces the company’s focus on supportive care for patients receiving cancer treatment.
FILKRI’s commercial introduction adds another option for managing neutropenia across its approved indications. Its availability, permanent billing code and patient support services may help healthcare providers navigate treatment access, while continued safety monitoring and appropriate prescribing remain essential. The launch also reflects the growing role of biosimilars in expanding choices within supportive oncology care.
Source: Accord BioPharma press release
