On 11 October 2024, Meiji Seika Pharma Co., Ltd. announced that the US Food and Drug Administration (FDA) has approved its Imuldosa™ (DMB-3115, ustekinumab-srlf), biosimilar to Janssen’s Stelara® (ustekinumab).
The FDA approval follows Accord BioPharma’s announcement in January 2024 that the FDA had accepted its Biologics Licence Application (BLA) for DMB-3115. DMB-3115 was jointly developed by Dong-A St and Meiji Seika Pharma, which granted Intas Pharmaceuticals (Accord BioPharma’s parent company) exclusive licensing rights worldwide excluding certain Asian countries, in an agreement announced in 2021. Under the agreement, Accord BioPharma is responsible for US commercialisation.
In October 2023, Accord BioPharma reached a settlement with Janssen that allows Accord to launch DMB-3115 in the US no later than 15 May 2025.
Previously approved ustekinumab biosimilars in the US are Samsung Bioepis’ Pyzchiva®(SB17, July 2024), Alvotech/Teva’s Selarsdi™ (April 2024), Amgen’s Wezlana® (October 2023) and Formycon/Fresenius Kabi’s Otulfi® (FYB202, September 2024).