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Alvotech announces EMA acceptance of MAA for AVT05
The Fly

Alvotech announces EMA acceptance of MAA for AVT05

Alvotech (ALVO) and Advanz Pharma announced that the European Medicines Agency has accepted a Marketing Authorization Application for AVT05, Alvotech’s proposed biosimilar to Simponi, a biologic used to treat several chronic inflammatory diseases. This is believed to be the first marketing authorization application filing announced globally for a biosimilar candidate to Simponi. The approvals process is anticipated to be completed in the fourth quarter of 2025.

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