FDA Review and Phase III Alert: Biocon’s Ustekinumab Biosimilar

On 16 May 2024, Biocon reported that the US’s FDA had accepted Biocon’s BLA for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway. Biocon had earlier signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson that allows Biocon to commercialize Bmab 1200, subject to regulatory approval, in the U.S. by no later than 22 February 2025. More recently, industry media has reported that Biocon’s Bmab 1200 is currently in Phase III for the treatment of Crohn’s Disease.