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Accord BioPharma has launched Filkri, a biosimilar version of Neupogen (filgrastim), in the US following the FDA approval in Jan 2026
Filkri was approved based on data showing its similarity to Neupogen, with no clinically meaningful differences. It is available in 300mcg/0.5mL & 480mcg/0.8mL PFS presentations, with pack sizes of one or 10 PFS…
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Regulatory momentum accelerated globally with multiple biosimilars securing key approvals and positive opinions, including Sandoz’s Enzeevu (Eylea biosimilar) in the US and Canada, Accord BioPharma’s Filkri (Neupogen biosimilar) US FDA approval, EC approvals for Gotenfia (Simponi biosimilar) and Ranluspec (Lucentis biosimilar), and CHMP positive opinions for tocilizumab and insulin biosimilars.
Strategic partnerships expanded regional access as companies including Alvotech, Bio-Thera Solutions, Formycon,…
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FDA has approved Filkri, a biosimilar to Neupogen (filgrastim), for pts receiving myelosuppressive CT, those with AML receiving induction or consolidation CT, cancer pts undergoing bone marrow transplant, pts with sev. chronic neutropenia, & pts exposed to myelosuppressive radiation
Approval was supported by 2 studies in healthy adults, with PK/PD assessed in one, &…

