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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