Accord Healthcare receives positive CHMP opinion for IMULDOSA®, a ustekinumab biosimilar to Stelara®

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Oct 19, 2024, 01:00 ET

Accord announces that the CHMP has issued a positive opinion for Imuldosa^® (development code: DMB-3115), a biosimilar to Stelara^®, indicated for a range of immunology conditions.
The approval of Imuldosa^® further enhances Accord Healthcare's biosimilar portfolio and strengthens Accord's Autoimmune Franchise building on existing leading brands.
Imuldosa^® will be the 5^th biosimilar for Accord in the EU, with a further 10 in various stages of development.

LONDON, Oct. 19, 2024 /PRNewswire/ -- Accord Healthcare Limited (Accord) a subsidiary of Intas Pharmaceuticals, announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorisation for Imuldosa^® (development code: DMB-3115), a biosimilar of Stelara^® (ustekinumab), marketed by Janssen Biotech Inc., a subsidiary of Johnson & Johnson.

Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which may play an important role in inflammatory and immune responses.

Mr. Paul Tredwell, Executive Vice President of Accord Healthcare, said, "We are delighted with the positive CHMP opinion for Imuldosa^®. This further strengthens our established autoimmune franchise, where Accord already has several leading speciality brands. The recommendation affirms Accord's continued strategy to expand its speciality business with an industry-leading portfolio, this positive opinion, combined with a further 10 biosimilars in development, reaffirms our commitment to improve access to value-based medicines for patients."

"We are truly excited by this partnership which, besides strengthening our existing biosimilar portfolio, also reinforces our long-term commitment towards bettering access to medicines for patients globally," said Mr Binish Chudgar, Executive Chairman and Managing Director of Intas Pharmaceuticals Ltd.

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According to the EMA CHMP positive opinion, DMB-3115 is highly similar to the reference product Stelara^® (ustekinumab) and has demonstrated comparable quality, safety and efficacy to Stelara^®. The MAA submission includes results from the phase III multi-regional clinical trial in patients with plaque psoriasis (NCT04785326). The study demonstrated a comparable efficacy and safety profile between DMB-3115 and Stelara^®.

Stelara^® is indicated for a range of immunology indications and has recorded global sales of US$19 billion of which US$3.2 billion sales coming from Europe as per IQVIA MAT June 2024 data.