EMA recommends approval for ustekinumab biosimilar Absimky and Imuldosa

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EMA recommends approval for ustekinumab biosimilar Absimky and Imuldosa

Biosimilares/Novedades | Posted 26/11/2024 0 Post your comment

On 17 October 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of marketing authorization for Accord’s Absimky and Imuldosa, both of which are ustekinumab biosimilars referencing Janssen/Johnson & Johnson’s Stelara.

Absimky and Imuldosa are approved for treating patients with autoimmune diseases, including plaque psoriasis, paediatric psoriatic arthritis, psoriatic arthritis, and Crohn’s disease. Additionally, Absimky is specifically indicated for ulcerative colitis.

Absimky/Imuldosa (DMB-3115) will be available as a 45 mg or 90 mg solution for injection in pre-filled syringes and as a 130 mg concentrate for solution for infusion.

The submission of the Marketing Authorization Application for Absimky/Imuldosa (DMB-3115) includes results from a Phase III multi-region trial in patients with plaque psoriasis. The study demonstrated comparable efficacy and safety profiles between the biosimilar product and Stelara.

Absimky/Imuldosa (DMB-3115) was developed jointly by Korea’s Dong-A ST and Japan’s Meiji Seika Pharma. In July 2021, they entered into an exclusive global license agreement with Intas Pharmaceuticals, granting worldwide commercialization rights for DMB-3115, excluding Korea, Japan, and certain other Asian countries. DMB-3115 will be marketed in Canada, the EU, and the UK by Intas’ subsidiary, Accord Healthcare, and in the US by Accord Biopharma.

By the end of September 2024, seven ustekinumab biosimilars had already been approved in the European Union [1].

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. EC approval for three ustekinumab biosimilar: Eksunbi, Fymskina, Otulfi[www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 26]. Available from: www.gabionline.net/biosimilars/news/ec-approval-for-three-ustekinumab-biosimilar-eksunbi-fymskina-otulfi

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