EMA Accepts Marketing Authorization Application For Alvotech's AVT05 (Golimumab)

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On November 4, 2024, Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05...

United States Food, Drugs, Healthcare, Life Sciences

On November 4, 2024, Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, Alvotech's biosimilar to Simponi® (golimumab), for the treatment of several chronic inflammatory diseases. The announcement "is believed to be the first marketing authorization application filing announced globally for a biosimilar candidate to Simponi." The approval process is anticipated to be completed in the fourth quarter of 2025.

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