Alvotech announced EMA accepted a Marketing Authorization Application for AVT03, a biosimilar candidate to Prolia® and Xgeva® (denosumab). AVT03 met primary endpoints in studies demonstrating clinical similarity to Prolia in efficacy, safety, immunogenicity, and pharmacokinetics. Alvotech partners with STADA Arzneimittel AG and Dr. Reddy’s Laboratories SA for AVT03 commercialization in Europe.