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CuraTeQ Biologics Wins European Medicines Agency's Positive Opinion for Neulasta Biosimilar

MT Newswires·07/24/2026 07:23:30
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07:23 AM EDT, 07/24/2026 (MT Newswires) -- The European Medicines Agency's Committee for Medicinal Products for Human Use recommended the approval of CuraTeQ Biologics' neutropenia drug Cavoley, which is a biosimilar to Amgen's Neulasta. Cavoley is intended to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients after cytotoxic chemotherapy, according to a Friday release. The committee's positive opinion is based on Cavoley's comparable quality, safety, and efficacy with Neulasta, which was approved for use in the European Union in August 2002. The drug will be subject to a final marketing authorization from the European Commission.