Denosumab biosimilar IND approval in China and teriparatide biosimilar launch in South Korea

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.

[1] Note: A previous version of this post stated that HLX14 was approved by the NMPA.  This is incorrect and has been revised to state that the IND application for HLX14 has been approved by the NMPA.

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