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FDA Accepts Alvotech/Dr Reddy’s BLA for Biosimilar Denosumab

Mar 18, 2025

In a joint press release on 18 March 2025, Alvotech and Dr Reddy’s announced that the US FDA has accepted their Biologic Licence Application (BLA) for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).

According to the companies, AVT03 will be supplied in a single-dose prefilled syringe containing 60 mg in a 1 mL solution, as well as a 120 mg/1.7 mL (70 mg/mL) solution in a single-dose vial.

In May 2024, Dr Reddy’s and Alvotech entered into a licence and supply agreement for the commercialisation of AVT03, under which Alvotech develops and manufactures the product and Dr Reddy’s will commercialise it exclusively in the US, and semi-exclusively in the EU and UK.

There are three denosumab biosimilars already approved in the US: Celltrion’s Stoboclo® and Osenvelt® (March 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (March 2024).

Over the past year, the FDA has accepted a number of denosumab biosimilar BLAs for review, including for: Amneal/mAbxience (March 2025), Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), Teva (October 2024), and Fresenius Kabi (May 2024).  Accord/Intas have also submitted an aBLA for INTP23 (denosumab, date of submission unknown).