Alvotech Makes It Four With Denosumab Trial
Study Begins For Firm’s AVT03 Proposed Prolia/Xgeva Biosimilar
Alvotech has begun its fourth biosimilar clinical trial program, announcing the start of studies for its AVT03 proposed denosumab rival to Prolia/Xgeva.
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In a busy week for Alvotech, the firm has announced an expansion of its partnership with Advanz to cover five further European biosimilars, at the same time as revealing two new pipeline assets. Meanwhile, the company has also dropped three products from an existing European partnership with Stada and has also terminated a development deal with BiosanaPharma.
As Alvotech reported its first annual financial results, the company spoke of the imminent FDA inspection at its Icelandic manufacturing facility. An earlier inspection has so far put the kibosh on US approval for Alvotech’s proposed Humira (adalimumab) biosimilar.
Sandoz has confirmed that its denosumab biosimilar BLA has been accepted for review by the US FDA. The company – which has previously characterized its development program as a frontrunner compared to other proposed Prolia/Xgeva rivals – indicated that it was “among the first” to file.