Stada Bags European Rights from Alvotech to Biosimilar of Amgen Blockbusters
Drug ApprovalPhase 3BiosimilarLicense out/inClinical Result
Pictured: Businessmen shaking hands after closing a deal/iStock, Tippapatt
Alvotech and Stada have expanded their alliance to include a clinical-stage biosimilar of Amgen’s blockbuster bone drugs Prolia and Xgeva, the companies announced Tuesday.
Prolia and Xgeva have the same active ingredient, denosumab, but are approved in different indications. Amgen provides Prolia as a treatment for osteoporosis, both in postmenopausal women at high risk of fracture and in men who need to increase bone mass. Physicians mainly use Xgeva to prevent fractures and other skeletal events in patients with bone metastases from solid tumors and multiple myeloma.
The products are among Amgen’s best-selling drugs, with the company reporting Prolia and Xgeva sales of $4 billion and $2.1 billion, respectively, in 2023. Both products are still growing. Prolia sales grew 8% in the first quarter of 2024, while revenues from Xgeva rose 5%.
Alvotech and Stada are preparing to provide patients and physicians with biosimilar alternatives to Prolia and Xgeva. Tuesday, Alvotech said Stada has gained semi-exclusive commercial rights for its proposed biosimilar copy of the Amgen drugs in Europe, including Switzerland and the U.K. Stada has also secured exclusive rights to the biosimilar candidate in some markets in Central Asia and the Middle East.
Investigators are comparing Alvotech’s AVT03 biosimilar candidate to denosumab in postmenopausal women with osteoporosis in a Phase III clinical trial. The study is scheduled to finish this year. Alvotech remains responsible for developing and manufacturing AVT03.
The patents protecting Prolia and Xgeva in Europe expired in 2022 and Sandoz received approval for the first biosimilar copies in the region in May 2024. Sandoz could launch its denosumab biosimilar in the U.S. in May 2025. Organon, which is partnered with Shanghai Henlius Biotech, has applied for approval of another denosumab biosimilar in the European Union.
Stada secured rights to AVT03 as part of a broader set of changes to its partnership with Alvotech. The companies partnered to commercialize seven biosimilars in Europe in 2019, leading to the approval of the Humira (adalimumab) biosimilar Hukyndra in 2021. Stada extended its rights to Hukyndra to include countries in Central Asia in parallel to the AVT03 deal.
Alvotech also granted Stada rights to a biosimilar of Stelara (ustekinumab) in parts of Central Asia. Stada already had rights to the product, Uzpruvo, in the E.U., where it received authorization earlier this year. Alvotech and Stada are preparing to launch Uzpruvo in Europe.
Stada is returning rights to a proposed biosimilar to the eye disease drug Eylea (aflibercept) to Alvotech. The action follows Stada’s launch of a biosimilar of Lucentis (ranibizumab), a drug that competes with Eylea.
Nick Paul Taylor is a freelance pharmaceutical and biotech writer based in London. He can be reached on LinkedIn.
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