On 21 May 2024, Alvotech and Dr Reddy’s announced that that they have entered into a licence and supply agreement for the commercialisation of AVT03 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva® in the US, EU and UK.
Under the agreement, Alvotech will develop and manufacture the product and Dr Reddy’s will commercialise it exclusively in the US, and semi-exclusively in the EU and UK. The agreement provides for an up-front payment to Alvotech, with additional payments upon certain regulatory and commercialisation milestones, plus sales-based payments.
Alvotech announced positive top-line results for AVT03 in January 2024, in a study comparing the pharmacokinetics, safety and tolerability of the biosimilar compared to Prolia® in healthy adults.