China-based Sinocelltech Group Ltd (SHA: 688520) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its biosimilar version of AbbVie’s (NYSE: ABBV) Humira (adalimumab). This approval encompasses all indications previously approved for Humira, which include a wide range of conditions such as rheumatoid arthritis, ankylosing spondylitis, psoriasis, Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, plaque psoriasis in children, and Crohn’s disease in children.
Humira’s Global and Chinese Market Presence
Humira, a landmark drug in the treatment of autoimmune diseases, was first approved globally in the United States in 2002 and made its way to China in 2010. It entered the National Reimbursement Drug List (NRDL) in 2021 with all indications covered, making it accessible to a broader patient population in China.
Competition in the Biosimilar Market
Prior to Sinocelltech’s approval, six other Humira biosimilars have been approved in China, manufactured by notable companies such as Bio-Thera, BioRay, Henlius, Sino Bio, Junshi/Mabwell, and Innovent. The entry of Sinocelltech’s adalimumab biosimilar further intensifies competition in the biosimilar market, offering more options for patients and healthcare providers in China.-Fineline Info & Tech