Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has accepted additional indication approval filings for its biosimilar HanDaYuan, which is modeled after AbbVie’s autoimmune therapy Humira (adalimumab). The company is seeking approval for HanDaYuan to treat polyarthritic juvenile idiopathic arthritis, pediatric plaque psoriasis, Crohn’s disease, and pediatric Crohn’s disease.
Originally approved in China in December 2020, HanDaYuan has already received market authorizations for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriasis, and uveitis. Wanbang Biopharmaceuticals Co., Ltd is tasked with the commercialization of the product in China. Notably, several other biosimilars of Humira have also gained approval in China, produced by companies including Bio-Thera, BioRay, Sinocelltech, Sino Bio, Junshi/Mabwell, and Innovent.- Flcube.com
