On 12 December 2024, Gedeon Richter and Hikma Pharmaceuticals announced that FDA has accepted for review Hikma’s BLA for RGB-14 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva®.
Pursuant to an exclusive licence agreement entered in December 2021, Hikma is responsible for FDA registration of RGB-14 and has exclusive rights to commercialise it in the US following approval. Gideon Richter is responsible for development.
Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in the US in March 2024. No other denosumab biosimilars have been approved in the US, although Fresenius Kabi’s BLA for its denosumab biosimilar (FKS518) was accepted in May 2024, Teva’s BLA for TVB-009P (denosumab) was accepted in October 2024 and Organon/Shanghai Henlius’ BLA for HLX14 (denosumab) was accepted in late October 2024. Celltrion filed an aBLA for CT-P41, biosimilar denosumab, in December 2023, which received a positive CHMP opinion on 12 December 2024.