Bio-Thera Solutions Ltd, a biopharmaceutical company based in Guangzhou, has announced the submission of Biologic License Applications (BLAs) to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for BAT2206, its biosimilar candidate to Johnson & Johnson’s (J&J, NYSE: JNJ) Stelara (ustekinumab), an auto-immune disease treatment.
Stelara, the first all-human ‘dual-targeted’ inhibitor of interleukin 12 (IL-12) and interleukin 23 (IL-23), has received five indication approvals in the US, covering a range of conditions including ulcerative colitis, Crohn’s disease, active psoriatic arthritis, and psoriasis in addition to plaque psoriasis. The drug was first approved in China in 2017 and achieved sales of USD 10.858 billion for J&J in 2023.
As Bio-Thera awaits regulatory decisions for its Stelara biosimilar in China, it has already secured commercialization partnerships for the drug in several key markets. The company has granted Hikma Pharmaceuticals USA Inc. rights for the US market, Biomm S.A. for Brazil, and Pharmapark LLC for Russia.- Flcube.com
