Accord BioPharma's Biologics License Application (BLA) for DMB-3115, a biosimilar to Janssen's Stelara® (ustekinumab), has been accepted by the US FDA.
DMB-3115 was jointly developed by Dong-A ST and Meiji Seika Pharma, with Intas Pharmaceuticals holding exclusive licensing rights, excluding specific Asian countries.
Accord BioPharma reached a settlement with Janssen in October 2023, allowing for a US launch of DMB-3115 no later than May 15, 2025, pending FDA approval.
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