Filkri Becomes Fifth FDA-Approved Neupogen Biosimilar

The FDA has approved Accord BioPharma’s Filkri (filgrastim-laha) as a biosimilar to Amgen’s Neupogen (filgrastim) to treat chemotherapy-associated neutropenia (low neutrophil counts).

The FDA’s approval of Filkri includes a broad set of indications aligned with those of the reference product Neupogen: patients receiving myelosuppressive chemotherapy for cancer; patients with acute myeloid leukemia (AML) undergoing induction or consolidation chemotherapy; patients undergoing bone marrow transplantation; individuals with severe chronic neutropenia; and patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome).

These uses aim to reduce the risk of infection by accelerating neutrophil recovery in patients whose immune defenses are weakened by cancer therapies or certain disease states.

Accord BioPharma is the US specialty division of Intas Pharmaceuticals, and represents another entry in the expanding biosimilar market for supportive care in oncology and related conditions.

Filkri is a biosimilar version of filgrastim, a granulocyte colony-stimulating factor (G-CSF). Filgrastim stimulates the bone marrow to produce neutrophils, a type of white blood cell crucial for fighting infections. It’s commonly used to reduce the duration of neutropenia in patients undergoing myelosuppressive chemotherapy and in other clinical settings where neutrophil counts are compromised.

Biosimilars are biological medicines that are highly similar to an FDA-approved reference biologic and have no clinically meaningful differences in safety, purity and potency. They generally enter the market after the original product’s patent and exclusivity protections expire, offering competitive alternatives that can help reduce treatment costs.

Filkri’s approval was supported by two randomized studies in healthy adults. One trial evaluated pharmacokinetics (PK) and pharmacodynamics (PD), while both assessed safety and immunogenicity against the reference product Neupogen. The data demonstrated comparable PK and PD profiles between Filkri and Neupogen, along with similar safety and immunogenicity outcomes.

Filkri isn’t the first filgrastim biosimilar approved in the US. It joins several others in a competitive class that has grown significantly over the past decade. Filkri adds to this roster, marking the fifth filgrastim biosimilar cleared by the FDA.

The other four FDA-approved biosimilars referencing Neupogen in the US include the first approved Neupogen biosimilar, Sandoz’s Zarxio (filgrastim-sndz), approved in 2015. The second, Nivestym (filgrastim-aafi) from Pfizer, was approved in 2018, followed by the 2022 approval of Releuko (filgrastim-ayow), developed by Kashiv BioSciences and Amneal Pharmaceuticals. The fourth entrant, Nypozi (filgrastim-txid) from Tanvex BioPharma, received approval in 2024.

All five products are biosimilars to Neupogen and are approved for the same core indications, including reducing the incidence of infection in patients with neutropenia associated with myelosuppressive chemotherapy, AML, bone marrow transplantation, severe chronic neutropenia and radiation exposure.

This growing class of biosimilars has helped widen access to filgrastim therapies and exert downward pressure on prices through competition.

Filkri expands Accord BioPharma’s supportive care offerings. The company already markets Udenyca (pegfilgrastim-cbqv), a biosimilar to Neulasta (pegfilgrastim) and several other biosimilars referencing well-known biologics used in oncology, immunology and bone disease.