Bio-Thera Solutions, Ltd., a commercial-stage biopharmaceutical company, announced that the China National Medical Products Administration (NMPA) has approved BAT1806, a biosimilar of Actemra (tocilizumab), in China. BAT1806 is the first tocilizumab biosimilar approved by the NMPA or any other regulatory agency around the world and has been approved for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), and cytokine release syndrome (CRS). BAT1806 is Bio-Thera Solutions’ third biosimilar to receive regulatory approval by the NMPA.
BAT1806, a tocilizumab injection developed by Bio-Thera Solution in accordance with the biosimilar guidelines of China’s NMPA, the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA), is a recombinant humanized monoclonal antibody targeting interleukin-6 receptor (IL-6R), which specifically binds to soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibits signaling mediated by sIL-6R or mIL-6R. The marketing authorization application for BAT1806/BIIB800 has been accepted by EMA and FDA. The reference product, Actemra, has been approved in the United States for the treatment of rheumatoid arthritis (RA), giant cell arthritis (GCA), systemic sclerosis-associated interstitial lung disease (SSc-ILD), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), cytokine release syndrome (CRS), and coronavirus disease 2019 (COVID-19). Comprehensive analytical similarity studies, non-clinical similarity studies and clinical studies have confirmed that BAT1806 is highly similar to the reference drug in terms of quality, safety and efficacy.
Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solution said, “We are delighted that BAT1806 has been approved as the world’s first tocilizumab biosimilar. This is a very important step for Bio-Thera in the field of rheumatology, and it is more important to patients as its approval provides a new treatment option to many patients with autoimmune conditions.” Dr. Li continues, “China is currently facing an unprecedented spread of the COVID-19 infections, and BAT1806 provides a treatment option to many hospitalized COVID-19 patients with severe lung conditions”.
Bio-Thera Solutions is developing several additional biosimilar products, including proposed biosimilars for Simponi, Stelara and Cosentyx, which are all currently in global Phase 3 studies, and a proposed biosimilar for Nucala, which is currently in a Phase 1 study.