On 29 September 2026, the Subject Expert Committee (SEC) under India’s Central Drugs Standard Control Organisation (CDSCO) recommended the approval of Alvotech/Dr Reddy’s Laboratories’ 120 mg/1 mL denosumab, biosimilar to Amgen’s Xgeva®, in a pre-filled syringe (PFS) with an automatic needle guard. This new presentation expands Alvotech/Dr Reddy’s denosumab portfolio in India, following the approval of its denosumab vial presentation (120 mg/1.7 mL solution for injection) in August 2017.
The approval is conditional on Dr Reddy’s Laboratories submitting an active post-marketing surveillance study protocol for the approved indications within three months and conducting the study in India and adding product label warnings for patients with phenylketonuria regarding the presence of phenylalanine in the product.
Dr Reddy’s and Alvotech entered into a licence and supply agreement in May 2024 for the commercialisation of AVT03 (denosumab), under which Alvotech develops and manufactures the product and Dr Reddy’s commercialises it exclusively in the US, and semi-exclusively in the EU and UK.
Alvotech also has semi-exclusive commercialisation agreements for European markets with STADA (June 2024) in relation to AVT03. STADA will market AVT03 as Kefdensis® (referencing Amgen’s Prolia®) and Zvogra® (referencing Xgeva®), while Dr. Reddy’s will market AVT03 as Acvybra® (referencing Prolia®) and Xbonzy® (referencing Xgeva®).