On 16 December 2025, China-based Mabwell announced that it has completed its first commercial shipment of its denosumab biosimilars outside China, although the destination(s) of the shipment is not disclosed in the press release.
Mabwell’s biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) are marketed in China as Mailishu® (approved March 2023 for treatment of osteoporosis in postmenopausal women at high risk of fracture) and Maiweijian™ (approved April 2024 for the treatment of giant cell tumour of the bone), respectively.
The first overseas shipment by Mabwell of the biosimilars comes shortly after Mabwell’s denosumab biosimilar licensee in Pakistan, Searle (under a July 2023 licence agreement), gained approval from Pakistan’s Drug Regulatory Authority to market and sell denosumab biosimilars in that country (announced 1 September 2025).
According to Mabwell, it has submitted marketing authorisation applications for its denosumab biosimilars in several other key markets, including Jordan, Egypt, and Brazil.