Posted by Michael Wonder on 25 Jul 2024
Bio-Thera Solutions announces regulatory filing acceptance for BAT2206, a proposed biosimilar to Stelara in the US and EU
24 July 2024 - The BAT2206 BLA and MAA are based on a robust analytical, non-clinical and clinical data package comparing BAT2206 to the reference product Stelara.
Bio-Thera Solutions today announced that the FDA has accepted the BLA for BAT2206, a proposed interchangeable biosimilar to Stelara (ustekinumab) seeking a commercial license in the US. In addition, Bio-Thera also announced that the EMA has accepted the MAA for BAT2206 seeking a commercial license in the European Union.
