Shanghai Henlius Biotech (Henlius) recently announced that China’s National Medical Products Administration (NMPA) has approved an investigation new drug (IND) application[1] of HLX14, a denosumab biosimilar. Denosumab is a recombinant humanized anti-RANKL monoclonal antibody for injection that is approved for the treatment of postmenopausal women with osteoporosis with a high risk of fractures.
South-Korea-based Daewon Pharmaceutical (Daewon) recently launched their teriparatide biosimilar TERROSA, to be marketed by Richter-Helm Biotec. Teriparatide is a recombinant form of parathyroid hormone (PTH) that is indicated for the treatment of osteoporosis in men and postmenopausal women and women with a high risk of fractures. TERROSA is the first biosimilar of teriparatide to be launched in Korea and the first biosimilar marketed by Daewon.