Posted by Michael Wonder on 29 Jul 2025
CHMP recommends EU approval of Henlius’ denosumab biosimilar HLX14
28 July 2025 - Shanghai Henlius Biotech announced today that the EMA's CHMP has adopted a positive opinion for HLX14, the company’s independently developed investigational denosumab biosimilar referencing Prolia/Xgeva (denosumab).
The positive opinion covers all approved indications of the reference products in the EU, including osteoporosis, prevention of skeletal-related events, and treatment of giant cell tumour of bone.
