At its October meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Accord HealthCare’s, Imuldosa® (DMB-3115) and Absimky® (DMB-3115), biosimilars to Janssen’s Stelara® (ustekinumab). Both biosimilars are indicated for plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease, with Absimky® additionally being indicated for ulcerative colitis.
In July 2021, Dong-A ST and Meiji Seika Pharma entered into an exclusive global licence agreement with Intas Pharmaceuticals, under which Intas received worldwide commercialisation rights for DMB-3115, excluding Korea, Japan and certain other Asian countries. Intas is commercialising DMB-3115 via its subsidiaries, Accord Healthcare in the EU, UK and Canada, and Accord Biopharma in the US.
Earlier this month, Imuldosa® was approved by the FDA as the fifth approved ustekinumab biosimilar in the US. Accord Biopharma reached a settlement with Janssen in October 2023, allowing DMB-3115 to launch in the US no later than 15 May 2025.
Previously approved ustekinumab biosimilars in Europe include Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024), Celltrion’s SteQeyma®/CT-P47 (August 2024), Amgen’s Wezenla™ (June 2024), Sandoz/Samsung Bioepis’ Pyzchiva®/SB17 (April 2024, launched July 2024) and Alvotech/Stada’s Uzpruvo® (January 2024, launched July 2024). Bio-Thera’s MAA for BAT2206 (ustekinumab) was accepted by the EMA in July 2024.