Alvotech and STADA have expanded their strategic alliance by partnering on AVT03, a biosimilar to Prolia® and Xgeva® (denosumab) for the treatment of osteoporosis and cancer-related bone loss. STADA will hold the marketing license for AVT03 in Europe, including Switzerland and the UK, as well as exclusive rights in selected markets in Central Asia and the Middle East. This collaboration builds on their previous alliance, which saw the successful launch of Hukyndra®, a biosimilar to Humira® (adalimumab).
The agreement stipulates that Alvotech will handle the development and manufacturing of AVT03 at its cutting-edge facility in Reykjavik, Iceland. STADA will take on the role of the marketing authorization holder once AVT03 receives approval and will have semi-exclusive commercial rights in Europe, Switzerland, and the UK, along with exclusive rights in certain Central Asian and Middle Eastern countries. Additionally, STADA will expand its commercial rights to include biosimilars to Humira® and Stelara® in CIS countries in Central Asia. Alvotech will regain commercial rights to AVT06, a proposed biosimilar to Eylea®.
STADA’s Global Specialty Head, Bryan Kim, expressed excitement about offering patients and clinicians a new treatment option with denosumab, building on their success with Movymia®, a teriparatide osteoporosis treatment. This alliance allows both companies to focus their resources efficiently and effectively.
Alvotech’s Chief Commercial Officer, Anil Okay, emphasized the importance of increasing patient access to affordable biologics in the denosumab market. He highlighted Alvotech’s commitment to biosimilar development and manufacturing, showcasing their expertise in the field.
Denosumab works by targeting the protein RANKL, which is crucial for the function and survival of osteoclasts responsible for bone resorption. By binding to RANKL, denosumab reduces osteoclast activity, leading to a decrease in bone resorption and cancer-induced bone destruction. Osteoporosis affects a significant portion of the European population, with millions of individuals suffering from the condition, particularly women.
The partnership between Alvotech and STADA demonstrates their dedication to providing high-quality, cost-effective biosimilars to patients worldwide. By working together, they aim to make a positive impact on healthcare outcomes and increase access to essential treatments.
For more information about Alvotech and STADA, investors and journalists can visit their respective websites or contact the companies directly. STADA’s commitment to consumer healthcare products, generics, and specialty pharma underscores their mission to improve global health outcomes and meet the diverse needs of patients around the world.