Genor Bio's Infliximab Biosimilar Set to Become China's Third Domestic Approval

On February 17, the NMPA official website showed that the marketing application for infliximab biosimilar of Yuxi Genor Biotechnology Co., Ltd. has entered the "under review" stage and is expected to be approved soon. If approved, this would be the third domestically produced infliximab biosimilar in China.

Infliximab, developed by Johnson & Johnson and Merck & Co., Inc., is a chimeric monoclonal antibody that specifically blocks tumor necrosis factor-alpha (TNF-α). It binds with high affinity to both the soluble form (sTNF-α) and the transmembrane form (tmTNF-α) of TNF-α, inhibiting the binding of TNF-α to its receptor and thereby rendering TNF biologically inactive.

The drug was first approved by the FDA for marketing in the U.S. in 1998, received approval in Europe the following year, and was approved for marketing in China in 2006 under the trade name Remicade®. The peak sales of Remicade reached 9.24 billion U.S. dollars. Despite facing competition from biosimilars, it still achieved sales of 4.077 billion U.S. dollars in 2020.

Despite being marketed in China for many years, the first infliximab biosimilar was only approved in July 2021, from Taizhou Mabtech Pharmaceutical. In September, Hisun Biopharm's infliximab also received marketing approval. JHBP (Yuxi) Genor Biotechnology Co., Ltd. followed as the third. After JHBP, Celltrion Pharma's imported biosimilar has also been submitted for marketing approval and is currently under review. Compared with other biosimilars, the competition for infliximab is relatively moderate overall.

Among several TNF-α antibody drugs, adalimumab, as the "blockbuster drug," faces the most intense competition. In China, five similar drugs have been approved, two are under review for marketing approval, and 20 are undergoing clinical trials, including products in Phase III clinical trials from five companies. Golimumab faces the least competition, with only one company, Bio-Thera Solutions (BAT2506), in Phase III clinical trials.

Detailed Competition of Key Biosimilars (Compiled by Insight Database, as of February 17, 2022)