Industry Blogs and Articles

Filkri Becomes Fifth FDA-Approved Neupogen Biosimilar

Accord BioPharma’s Filkri (filgrastim‑laha) received FDA approval as the fifth biosimilar to Amgen’s Neupogen. The indication set mirrors Neupogen’s, covering chemotherapy‑induced neutropenia, AML, bone‑marrow transplant, severe chronic neutropenia, and radiation‑induced syndrome. Approval was based on two randomized trials in healthy adults showing comparable pharmacokinetics, pharmacodynamics, safety and immunogenicity. Filkri joins four existing filgrastim biosimilars, expanding Accord’s oncology supportive‑care portfolio.