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Accord BioPharma’s Filkri (Biosimilar, Neupogen) Receives the US FDA Approval

Shots: 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, &…

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CuraTeQ

CuraTeQ Biologics Reports the Health Canada’s NOC for Dyrupeg (Biosimilar, Neulasta) 

Shots:  CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, has received NOC from the BRDD for Dyrupeg, a biosimilar to Neulasta (pegfilgrastim)  Dyrupeg (pegfilgrastim) is a long-acting form of filgrastim that mimics human G-CSF, stimulating bone marrow to increase white blood cell production and treat neutropenia  In 2025, Dyrupeg received marketing authorization from the EC and the UK MHRA, with three additional CuraTeQ biosimilar…

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