Shots:
The NMPA has accepted NDA for HLX14, a biosimilar version of denosumab, in the 120mg (1.7mL) per vial strength presentation
NDA was based on extensive data, incl. analytical similarity studies, non-clinical & clinical comparative studies, where HLX14 at the 120 mg (1.7 mL) per vial strength showed similarity to its reference drug in terms…
