Biosimilar Approval Updates in Europe and China

Full frame of molecular structure of liquids in motion.

Full frame of molecular structure of liquids in motion.

On April 25, 2024, the Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion, recommending the granting of marketing authorization for Biogen Netherlands B.V.’s biosimilar TOFIDENCE (tocilizumab), for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA) and coronavirus disease 2019 (COVID-19).  Tocilizumab is a recombinant humanized anti-human interleukin-6 receptor (IL-6R) monoclonal antibody of the immunoglobulin IgG1 subclass.  TOFIDENCE will be available in 20 mg/ml concentrate solution for infusion. 

On April 25, 2024, CHMP also adopted a positive opinion recommending the granting and marketing authorization for Amgen Technology (Ireland) UC’s biosimilar WEZLANA (ustekinumab), for the treatment of plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis and Crohn’s disease in adults.  Ustekinumab is a human IgG1κ monoclonal antibody that binds to the p40 protein subunit shared by interleukin-12 (IL-12) and IL-23. WEZLANA will be available as 45 and 90 mg solution for injection and 130 mg concentrate for solution for infusion. 

On April 8, 2024, Mabwell, a bio pharmaceutical company based in Shanghai, announced marketing authorization approval of its denosumab injection (MAIWEIJIAN) developed by its wholly owned subsidiary T-mab.  MAIWEIJIAN is the first denosumab biosimilar (120mg) approved for marketing in China.  MAIWEIJIAN is a fully human recombinant anti-RANKL monoclonal antibody injection, approved to treat giant cell tumor of the bone that is unresectable or where surgical resection may lead to severe functional impairment, including in adults and adolescents with mature skeletal development (defined as having at least one mature long bone and a weight of ≥ 45kg). 

迈卫健中国首款地舒单抗生物类似药 (120mg) 获批上市  – 聚焦大分子 (