BRIEF—Latest EMA/CHMP biosimilars opinions

At its May meeting, the European Medicines Agency’s (EMA) human medicines committee (CHMP) adopted positive opinions for three biosimilar medicines:

Bomyntra (denosumab), Fresenius Kabi for the prevention of skeletal related events in adults with advanced malignancies involving bone and the treatment of adults and skeletally mature adolescents with giant cell tumor of bone.

C (denosumab), also from Fresenius Kabi, for the treatment of osteoporosis, a disease that makes bones fragile, in postmenopausal women and in men at increased risk of fractures.