The European Commission (EC) has granted marketing authorization to Accord Healthcare's Imuldosa (ustekinumab-biosimilar, development code: DMB-3115) for the treatment of immune-mediated inflammatory diseases. This approval, announced December 16, 2024, allows Accord Healthcare to market Imuldosa across all 27 EU member states, plus Iceland, Norway, and Liechtenstein.
The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in October 2024. The decision was based on a comprehensive data package, including analytical, non-clinical, and clinical similarity data. A pivotal multi-regional Phase III clinical trial in patients with plaque psoriasis demonstrated therapeutic equivalence between DMB-3115 and Stelara, alongside a comparable safety profile.
Clinical Equivalence and Safety Profile
The Phase III trial, which formed the cornerstone of the approval, confirmed that Imuldosa achieves similar efficacy to Stelara in treating plaque psoriasis. The study's primary outcome demonstrated no significant difference in therapeutic effect between the biosimilar and the originator product. Furthermore, the safety profile of Imuldosa was found to be comparable to that of Stelara, addressing critical concerns about immunogenicity and adverse events.
Commercialization and Market Impact
With marketing authorization secured, Accord Healthcare is poised to launch Imuldosa in the European ustekinumab market, which is currently valued at approximately €2.9 billion (US$3.18 billion) according to IQVIA MAT June 2024 data. Intas Pharmaceuticals holds exclusive licensing rights to commercialize Imuldosa worldwide, excluding Japan, Korea, and certain other Asian countries. The US FDA had already approved Imuldosa on October 10, 2024.
Joe Dunford, VP of Speciality Brands at Accord, stated, "Accord is committed to becoming a significant player in the autoimmune space, and we are delighted that the European Commission (EC) has granted marketing authorisation for our fifth biosimilar in Europe, Imuldosa. This approval ensures that patients have access to high-quality therapies in Europe and beyond. We remain dedicated to advancing our biosimilar pipeline, with the goal of launching 20 biosimilars by 2030."
Ustekinumab Mechanism and Indications
Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), both of which play a crucial role in inflammatory and immune responses. Stelara, the reference product, is indicated for a range of immune-mediated inflammatory diseases, including plaque psoriasis, psoriatic arthritis, and Crohn's disease. According to IQVIA data, Stelara recorded global sales of US$ 19 billion, with US$ 3.2 billion originating from Europe.
Development Collaboration
The development of IMULDOSA began in 2013 as a joint project between Dong-A Socio Holdings and Meiji Seika Pharma. Dong-A ST assumed responsibility for the project in July 2020 to ensure efficient global execution. In July 2021, Dong-A ST signed a global out-licensing agreement with Intas Pharmaceuticals for IMULDOSA.
