Stada Secures European Rights to Amgen Biosimilar from Alvotech

Alvotech and Stada have expanded their collaboration to include a clinical-stage biosimilar of Amgen’s widely used bone drugs, Prolia and Xgeva. Both medications share the same active ingredient, denosumab, but are approved for different medical conditions. Prolia is prescribed for osteoporosis treatment, especially in postmenopausal women at a high risk of fractures and in men requiring increased bone mass. On the other hand, Xgeva is primarily used to prevent fractures and other skeletal complications in patients with bone metastases from solid tumors and multiple myeloma.

Amgen has reported significant sales from both products, with Prolia generating $4 billion and Xgeva bringing in $2.1 billion in 2023. Both drugs continue to see growth, with Prolia sales increasing by 8% in the first quarter of 2024 and Xgeva revenues rising by 5%.

Alvotech and Stada are positioning themselves to offer biosimilar alternatives to these successful medications. Alvotech announced that Stada has obtained semi-exclusive commercial rights for their proposed biosimilar version of the Amgen drugs in Europe, including Switzerland and the U.K. Additionally, Stada has secured exclusive rights to the biosimilar candidate in certain regions within Central Asia and the Middle East.

Currently, researchers are evaluating Alvotech’s AVT03 biosimilar candidate against denosumab in a Phase III clinical trial involving postmenopausal women with osteoporosis. The study is expected to conclude this year. Alvotech remains in charge of the development and manufacturing of AVT03.

The patents for Prolia and Xgeva in Europe expired in 2022, paving the way for competition. Sandoz received approval for the first biosimilar copies in the region in May 2024 and is expected to launch its denosumab biosimilar in the U.S. by May 2025. Another company, Organon, in partnership with Shanghai Henlius Biotech, has sought approval for a different denosumab biosimilar in the European Union.

Stada secured rights to AVT03 as part of a broader revision of its partnership with Alvotech. The two companies had originally teamed up to commercialize seven biosimilars in Europe in 2019, resulting in the approval of the Humira (adalimumab) biosimilar, Hukyndra, in 2021. In parallel with the AVT03 deal, Stada extended its rights to Hukyndra to cover countries in Central Asia.

Additionally, Alvotech granted Stada rights to a biosimilar of Stelara (ustekinumab) in some parts of Central Asia. Stada already held rights to this product, known as Uzpruvo, in the E.U., where it received authorization earlier this year. Alvotech and Stada are preparing for Uzpruvo’s market launch in Europe.

As part of these broader changes, Stada is returning rights for a proposed biosimilar to the eye disease medication Eylea (aflibercept) to Alvotech. This decision follows Stada’s launch of a biosimilar for Lucentis (ranibizumab), a competing drug for Eylea.