Approval of Denosumab biosimilar and launch of teriparatide biosimilar in China and South Korea

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Shanghai Henlius Biotech (Henlius) recently announced that China’s National Medical Products Administration (NMPA) has approved 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 South Korea and the first biosimilar marketed by Daewon.

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