When was infliximab launched?

Infliximab (Infliximab) is a monoclonal antibody targeting tumor necrosis factor alpha (TNF-α). It is one of the first biologics approved for various immune-mediated diseases in the world. The brand name of its original drug is Remicade, which was jointly developed by Janssen Biotech and Merck. It is one of the TNF-α inhibitors currently widely used around the world. It has important therapeutic significance in many fields such as rheumatoid arthritis, ankylosing spondylitis, psoriasis, Crohn's disease and ulcerative colitis.

Infliximab was first approved by the US FDA on August 24, 1998 for the treatment of patients with moderately to severely active Crohn's disease (CD). Subsequently, it was approved by the EU EMA on August 13, 1999, with the same trade name of Remicade, and officially entered the European market. As the first generation TNF-α inhibitor, the launch of Infliximab marks the official revolutionary progress of biological targeted therapy in the field of autoimmune diseases.

In the Chinese market, the brand name of the original drug of infliximab is Leike, which was introduced by Johnson & Johnson and was officially approved by the National Medical Products Administration (NMPA) on June 16, 2021. Although it was launched slightly later in China than in Europe and the United States, its application in the fields of rheumatism, immunity and digestive system has rapidly expanded domestically, and it has been gradually included in the medical insurance catalog, benefiting a large number of patients.

It is worth noting that as the biologics market matures, a number of infliximab biosimilars (biosimilars) have been approved one after another, including Remsima, Inflectra, etc. These biosimilars are widely used in the US, European and Asian markets, and provide more affordable treatment options. The launch of biosimilar drugs not only promotes market competition, but also improves drug accessibility and is an important supplement to the long-term management of chronic diseases.

Reference materials:https://www.drugs.com/infliximab.html