Accord BioPharma's Ustekinumab Biosimilar BLA Accepted by FDA, Launch Expected by May 2025

Key Insights

• 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.

Accord BioPharma, a subsidiary of Intas Pharmaceuticals, has announced that the FDA has accepted its BLA for DMB-3115, a proposed biosimilar to Janssen’s Stelara® (ustekinumab). This acceptance marks a significant step toward providing a more affordable treatment option for patients requiring ustekinumab. The settlement with Janssen permits launch by 15 May 2025.

DMB-3115 was jointly developed by Dong-A ST and Meiji Seika Pharma. Intas Pharmaceuticals holds exclusive worldwide licensing rights, excluding certain Asian countries, per an agreement announced in 2021. Accord BioPharma will handle the commercialization of DMB-3115 in the United States.

The settlement agreement reached with Janssen in October 2023 paves the way for Accord to launch DMB-3115 in the US market by May 15, 2025, contingent upon FDA approval. This development promises to introduce competition in the ustekinumab market, potentially lowering costs and increasing patient access to this important biologic medication.