Bio-Thera Solutions disclosed on 16 July that US regulator the Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for BAT2506, a biosimilar version of Johnson & Johnson's (J&J) TNF-α inhibitor Simponi (golimumab). The drug, developed for autoimmune conditions like rheumatoid arthritis (RA), generated USD 2.19 billion in 2024 for J&J.

BAT2506 was developed in compliance with biosimilar guidelines from China's National Medical Products Administration (NMPA), Europe's European Medicines Agency (EMA) and the US FDA. Bio-Thera has now secured regulatory filings for BAT2506 in Brazil, China, Europe and the US. The biosimilar aims to expand patient access to golimumab therapy, currently approved in China for RA and ankylosing spondylitis.

According to PharmCube's NextBiopharm® database, BAT2506 is one of two golimumab biosimilars currently under review globally, with three other projects still in pre-clinical stage. Click here to request a free trial for NextBiopharm®.