Alvotech Expands European Presence with Successful Nasdaq Stockholm Listing
• Alvotech's Swedish Depository Receipts (SDRs) offering was multiple times oversubscribed, attracting over 3,000 new shareholders and raising approximately SEK 39 million.
• The biosimilar developer's strategic expansion includes acquiring Xbrane's R&D operations at the Karolinska life-science hub, strengthening its research capabilities and establishing a footprint in Sweden's biotech sector.
• Trading of Alvotech's SDRs on Nasdaq Stockholm commenced on May 19, 2025, under the ticker "ALVO SDB," enhancing the company's access to Nordic and European investors and capital markets.
FDA Accepts Alvotech and Teva's Biosimilar Application for Golimumab (AVT05)
• The FDA has accepted the BLA for AVT05, a biosimilar to Simponi/Simponi Aria (golimumab), marking the first such acceptance in the U.S.
• AVT05 is intended for inflammatory conditions like rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.
• The FDA's decision on AVT05 is expected in Q4 2025, potentially offering a cost-saving alternative for patients.
• Clinical studies have demonstrated comparable efficacy, safety, and immunogenicity between AVT05 and the reference golimumab.
EMA Accepts Alvotech's Biosimilar Application for Simponi (Golimumab)
• The European Medicines Agency (EMA) has accepted Alvotech's marketing authorization application for AVT05, a biosimilar to Simponi (golimumab).
• AVT05 is intended for treating chronic inflammatory diseases, potentially expanding treatment options for patients across Europe.
• Clinical studies have demonstrated comparable efficacy, safety, and immunogenicity between AVT05 and Simponi in rheumatoid arthritis patients.
• The approval process is anticipated to be completed in the fourth quarter of 2025, marking a significant step for Alvotech and Advanz Pharma.
EMA Accepts Alvotech's Biosimilar AVT03 for Prolia and Xgeva
• The European Medicines Agency (EMA) has accepted Alvotech's Marketing Authorization Application for AVT03, a biosimilar candidate to Prolia and Xgeva.
• AVT03 demonstrated clinical similarity to Prolia in terms of efficacy, safety, immunogenicity, and pharmacokinetics in clinical studies.
• Alvotech has partnered with STADA Arzneimittel AG and Dr. Reddy’s Laboratories SA for commercialization of AVT03 in Europe.
• The European denosumab market is valued at approximately US$1 billion, and AVT03 could expand patient access at lower costs.
© Copyright 2025. All Rights Reserved by MedPath