China-based Bio-Thera Solutions Inc. (SHA: 688177) announced that the market filings for its biosimilars BAT2306 and BAT2506 have been accepted for review by China’s National Medical Products Administration (NMPA) and the European Medicines Agency (EMA), respectively. BAT2306 is a biosimilar version of Novartis’ (NYSE: NVS) Cosentyx (secukinumab), while BAT2506 is a biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) Simponi (golimumab).
BAT2306: Secukinumab Biosimilar
Secukinumab was first approved in China in March 2019 for use in adult patients with moderate to severe plaque psoriasis and later approved for ankylosing spondylitis in April 2020. BAT2306, with its active pharmaceutical ingredient being an IgG1 kappa subtype monoclonal antibody expressed in Chinese hamster ovary cells, specifically binds to IL-17A and IL-17A/F, inhibiting the autoimmune inflammatory response mediated by IL-17.
BAT2506: Golimumab Biosimilar
Golimumab, a human tumor necrosis factor-α (TNF-α) monoclonal antibody (mAb), gained China market approval in 2018 to treat active ankylosing spondylitis or moderate to severe active rheumatoid arthritis (RA) in patients responding poorly to antirheumatic drugs in combination with methotrexate. BAT2506 is developed according to relevant guidelines in China, the US, and the EU. In May of last year, STADA Arzneimittel AG signed a licensing deal with Bio-Thera, acquiring exclusive commercialization rights to the biosimilar in the European Union (EU), the UK, Switzerland, and other European markets.
Future Outlook
With the acceptance of its biosimilars for review by key regulatory agencies, Bio-Thera Solutions is poised to expand its market presence in both China and Europe. This development underscores the company’s commitment to advancing biosimilar therapies and addressing unmet medical needs in autoimmune and inflammatory diseases.-Fineline Info & Tech
