Alvotech and STADA add to strategic alliance through denosumab partnership

Core Viewpoint - Alvotech and STADA are expanding their strategic alliance to include the development and marketing of AVT03, a biosimilar referencing Prolia®/Xgeva® (denosumab), aimed at treating osteoporosis and cancer-related bone loss in Europe and selected markets in Central Asia and the Middle East [1][2]. Group 1: Partnership Details - Alvotech will handle the development and manufacturing of AVT03 at its facility in Reykjavik, Iceland, while STADA will hold the marketing authorization and assume semi-exclusive commercial rights in Europe, including Switzerland and the UK [2]. - The partnership also extends STADA's commercial rights for biosimilars to Humira® and Stelara® in Commonwealth of Independent States (CIS) countries in Central Asia [2]. Group 2: Market Opportunity - STADA's Global Specialty Head highlighted the opportunity to offer denosumab as a treatment option, leveraging their existing market leadership with Movymia®, a teriparatide osteoporosis treatment [3]. - An estimated 32 million Europeans aged 50 and older had osteoporosis in 2019, with a direct cost of osteoporotic fractures in the EU, Switzerland, and the UK amounting to €56.9 billion (US$61.9 billion) [4]. Group 3: Product Information - AVT03 is an investigational biosimilar candidate for Prolia® and Xgeva® (denosumab), which is a human monoclonal IgG2 antibody targeting RANKL, crucial for osteoclast function and survival [5]. - Denosumab's mechanism involves binding to RANKL, reducing osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction [3][5]. Group 4: Company Background - Alvotech is focused on developing and manufacturing biosimilar medicines, aiming to be a global leader in the biosimilar space with a pipeline of eight candidates targeting various diseases [6][7]. - STADA Arzneimittel AG operates under a three-pillar strategy of consumer healthcare, generics, and specialty pharma, achieving group sales of EUR 3,734.8 million and EBITDA of EUR 802.1 million in 2023 [8].