Sinovac Biotech's Infliximab Biosimilar Approved in Thailand
en.Wedoany.com Reported - On August 18, Reminton®, an infliximab biosimilar introduced by Sinovac Biotech and developed by MabTech, was approved for marketing by the Thai Food and Drug Administration, obtaining regulatory clearance for sale in the Thai market.
Reminton®, developed and manufactured by Taizhou MabTech Pharmaceutical Co., Ltd., is a recombinant chimeric monoclonal antibody against tumor necrosis factor-alpha. The product was approved for marketing by China's National Medical Products Administration in July 2021, with approval number Guoyao Zhunzi S20210025, making it the first infliximab biosimilar approved for marketing in China. Indications approved in China include rheumatoid arthritis, ankylosing spondylitis, psoriasis, adult ulcerative colitis, Crohn's disease in adults and children aged 6 years and above, as well as fistulizing Crohn's disease.
Sinovac Biotech and MabTech signed an exclusive international commercialization license agreement in 2021, under which Sinovac Biotech is responsible for the commercialization of Reminton® in regions outside mainland China, Japan, Europe, and North America, while MabTech is responsible for product manufacturing and providing registration documentation. Prior to the approval in Thailand, the product had already obtained market access approvals in Peru, Indonesia, Pakistan, Bangladesh, and Malaysia.
