EMA confirms acceptance of marketing application for AVT03, a proposed biosimilar to Prolia and Xgeva

Alvotech

10 October 2024 - Alvotech announced today that the EMA has accepted a marketing authorisation application for AVT03, a proposed biosimilar candidate to Prolia and Xgeva (denosumab).

Alvotech develops and manufactures AVT03. STADA Arzneimittel and Dr. Reddy’s Laboratories, have entered into agreements with Alvotech for the commercialisation of AVT03, each partner with semi-exclusive commercial rights in Europe, including Switzerland and the UK.

Read Alvotech press release

Michael Wonder

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Michael Wonder

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Medicine , Europe , Biosimilar , Dossier