Blog
Big Molecule Watch
November 6, 2024

EMA Accepts Marketing Authorization Application for Alvotech’s AVT05 (golimumab)

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.

The post EMA Accepts Marketing Authorization Application for Alvotech’s AVT05 (golimumab) appeared first on Big Molecule Watch.