TL/DR –
The CHMP issued a positive opinion for Imuldosa (DMB-3115), a biosimilar to Stelara, which is used for a range of immunology conditions. The positive opinion is based on a comprehensive package of data, including a phase III clinical trial that showed therapeutic equivalence between DMB-3115 and Stelara. Imuldosa was already approved by the USFDA in October 2024, and Intas Pharmaceuticals holds exclusive licensing rights to commercialize Imuldosa worldwide, excluding Japan, Korea, and certain other Asian countries.
Accord’s Imuldosa® Receives Positive CHMP Opinion
Accord Healthcare announced on October 19, 2024, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for Imuldosa® (DMB-3115). This product is a biosimilar to Stelara®, marketed by Janssen Biotech Inc., a subsidiary of Johnson & Johnson, and it is indicated for a range of immunology conditions.
The CHMP positive opinion was based on a comprehensive package of analytical, non-clinical, and clinical similarity data, including a phase III clinical trial in patients with plaque psoriasis. It confirmed therapeutic equivalence between DMB-3115 and Stelara®, along with a comparable safety profile.
This positive opinion paves the way for the authorization of Imuldosa® in the EU ustekinumab market, which is valued at approximately €2.9 billion (US$3.18 billion) according to IQVIA MAT June 2024 data.
Imuldosa® Commercialization
Imuldosa® has already been approved by the USFDA on October 10, 2024, and Intas Pharmaceuticals holds exclusive licensing rights to commercialize it worldwide, excluding Japan, Korea, and some other Asian countries. Through its global subsidiaries, Intas plans to market DMB-3115.
Imuldosa® in Autoimmune Therapy
Imuldosa® (ustekinumab biosimilar) is a human monoclonal antibody targeting cytokines interleukin-12 and interleukin-23, playing a crucial role in inflammatory and immune responses. The use of Imuldosa® will further enhance Accord Healthcare’s biosimilar portfolio and strengthen its presence in the autoimmune therapy area.
Accord’s Executive Chairman, Mr Binish Chudgar, expressed excitement about this partnership, highlighting their commitment to improving access to top-quality biosimilar medicines globally. Echoing these sentiments, Executive Vice President of Accord Healthcare, Mr. Paul Tredwell, affirmed their commitment to broadening access to high-quality biologic therapies and their goal to launch 20 biosimilars by 2030.
A representative for Dong-A ST & Meiji stressed their commitment to ensuring DMB-3115’s global market availability.
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