Biosimilar Tocilizumab Injection approved for marketing

Recently, the Tocilizumab Injection (Chinese trade name:施瑞立) of Bio-Thera Solutions, Ltd. is approved for marketing by China NMPA. This drug is the first Tocilizumab Injection biosimilar approved in China, which is indicated for rheumatoid arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome.

Tocilizumab is a recombinant humanized monoclonal antibody against the human interleukin-6 (IL-6) receptor that specifically binds to soluble and membrane-bound IL-6 receptors and inhibits signal transduction mediated by IL-6 receptors. At present, the Tocilizumab Injection has been included in the Diagnosis and Treatment Protocol for COVID-19 Infection (Tentative 10th Edition) and Diagnosis and Treatment Protocol for Severe Cases of Covid-19 Infection (Tentative 4th Edition), which can be used for severe cases with significantly elevated IL-6 levels detected by laboratory.