Alvotech and STADA are extending their existing collaboration to include AVT03 a biosimilar to Prolia and Xgeva (denosumab), indicated for osteoporosis and bone cancer, respectively.

Denosumab is a human monoclonal IgG2 antibody that targets the RANKL protein, which is essential for the formation, function, and survival of osteoclasts.

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

STADA will hold the marketing authorisation, upon approval of AVT03, and will assume semi-exclusive commercial rights in Europe, including Switzerland and the UK.

The German drugmaker will also obtain exclusive commercial rights to AVT03in select countries in Central Asia and the Middle East.

AVT03 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.

STADA global speciality 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.”

In addition to the agreement for AVT03, the two companies have agreed to extend STADA’s commercial rights to biosimilars to Humira (adalimumab) and Stelara (ustekinumab).

As per the agreement, STADA will get rights to biosimilars to Humira and Stelara in Commonwealth of Independent States (CIS) countries in Central Asia.

Furthermore, Alvotech will regain commercial rights to AVT06, a biosimilar to Eylea (aflibercept).

Alvotech chief commercial officer Anil Okay 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.”

Earlier this year, Alvotech and its partner Teva Pharmaceuticals announced the US Food and Drug Administration (FDA) approval for Selarsdi (ustekinumab-aekn) as a biosimilar to Stelara.