Accord’s BLA for its Ustekinumab (Stelara®) Biosimilar Accepted by FDA; Settlement with Janssen Permits Launch by 15 May 2025 | Pearce IP
Accord BioPharma's BLA for DMB-3115, a biosimilar to Janssen’s Stelara®, accepted by FDA. Developed by Dong-A St and Meiji Seika Pharma, with Intas holding exclusive rights outside certain Asian countries. Accord to commercialize in US, with launch by May 2025 following FDA approval and Janssen settlement.
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Accord’s BLA for its Ustekinumab (Stelara®) Biosimilar Accepted by FDA; Settlement with Janssen Permits Launch by 15 May 2025 | Pearce IP
Accord BioPharma's BLA for DMB-3115, a biosimilar to Janssen’s Stelara®, accepted by FDA. Developed by Dong-A St and Meiji Seika Pharma, with Intas holding exclusive rights outside certain Asian countries. Accord to commercialize in US, with launch by May 2025 following FDA approval and Janssen settlement.