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

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.

References for media:

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.

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