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Alvotech, STADA add to strategic alliance through denosumab partnership

AVT03 is a clinical-stage biosimilar candidate referencing the Prolia/Xgeva medicines for osteoporosis and cancer-related bone loss, respectively.
Levy

Alvotech and STADA are 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.

Under the terms of the agreement, Alvotech will be responsible for development and manufacturing at its 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.

In parallel with the commercial agreement for AVT03, the two partners have agreed to extend STADA’s commercial rights to biosimilars to Humira (adalimumab) and Stelara (ustekinumab) to Commonwealth of Independent States countries in Central Asia. Alvotech also will regain commercial rights from STADA to AVT06, a proposed biosimilar to Eylea (aflibercept).

[Read more: Alvotech, Dr. Reddy’s collaborate for biosimilar candidate to Prolia, Xgeva]

STADA’s global specialty head, Bryan Kim, said, “As European market leader with our teriparatide osteoporosis treatment, Movymia, STADA sees a major opportunity to offer patients and clinicians a further treatment with denosumab. With a strong presence in oncology among our six currently marketed biosimilars, broadening our alliance with Alvotech enables us to direct our resources efficiently and effectively.”

Anil Okay, chief commercial officer of Alvotech, said, “We look forward to continuing to work with STADA on increasing patient availability of more affordable biologics in the denosumab market, as we have already done with our citrate-free, high-concentration biosimilar to Humira. This expansion of our commercial alliance further validates Alvotech’s unique focus on biosimilar development and manufacturing, strong end-to-end capability and expertise.”

[Read more: Alvotech announces strategic refinancing agreement]

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