Icelandic company Alvotech (Nasdaq: ALVO) and Germany’s STADA Arzneimittel (ETR: SAZ) are strengthening their existing strategic alliance for high-quality, cost-effective biosimilars by extending their partnership to cover AVT03, a clinical-stage biosimilar candidate referencing the Prolia/Xgeva (denosumab) medicines for osteoporosis and cancer-related bone loss respectively.
Alvotech will be responsible for development and manufacturing at its state-of-the-art facility in Reykjavik, Iceland. STADA will become marketing authorization holder, upon approval of AVT03, and will assume semi-exclusive commercial rights in Europe, including Switzerland and the UK, as well as exclusive commercial rights in selected countries in Central Asia and the Middle East.
Developed by US biotech major Amgen (Nasdaq: AMGN) and initially approved in 2010, denosumab is a big seller for the company, both as Prolia for the treatment of osteoporosis and Xgeva for bone cancer. Prolia alone generated sales of $4 billion in 2023.
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