AHMEDABAD, India, Oct. 19, 2024 --

  • Accord announces that the CHMP has issued a positive opinion for Imuldosa® (development code: DMB-3115), a biosimilar to Stelara®, indicated for range of immunology conditions.
  • The CHMP positive opinion is based on a comprehensive package of analytical, non-clinical, and clinical similarity data, including a multi-regional phase III clinical trial in patients with plaque psoriasis. The study confirmed therapeutic equivalence between DMB-3115 and Stelara®, alongside a comparable safety profile.
  • The CHMP's positive opinion paves the way for the authorization of Imuldosa® in the EU ustekinumab market, valued at approximately €2.9 billion (US$3.18 billion) according to IQVIA MAT June 2024 data.
  • Intas holds exclusive licensing rights to commercialize Imuldosa® worldwide, excluding Japan, Korea, and certain other Asian countries. Imuldosa® was already approved by the USFDA on October 10, 2024.
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Accord Healthcare Limited (Accord) 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.  In July 2021, Dong-A ST and Meiji Seika Pharma entered into an exclusive global license agreement with Intas Pharmaceuticals, granting them worldwide commercialization rights for DMB-3115, excluding Korea, Japan, and certain Asian countries. Intas Pharmaceuticals plans to commercialize DMB-3115 through its global subsidiaries, Accord BioPharma in the US and Accord Healthcare in the EU, UK, and Canada.

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. Stelara® is indicated for range of immunology indications and has recorded global sales of US$ 19 billion of which US$D 3.2 billion sales coming from Europe as per IQVIA MAT Jun'24 data.

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

Mr. Paul Tredwell, Executive Vice President of Accord Healthcare said, " We are delighted with the positive CHMP opinion for Imuldosa®, a biosimilar to Ustekinumab. This recommendation affirms the robust scientific approach behind our goal of broadening access to high-quality biologic therapies for patients in Europe and beyond. Upon approval by the European Commission, Imuldosa® will become Accord's fifth biosimilar in Europe. Building on this success, we remain committed to advancing our biosimilar pipeline and aim to launch 20 biosimilars by 2030."

A spokesperson for Dong-A ST & Meiji stated, "We will spare no effort to ensure DMB-3115 is supplied to the global market."

According to the EMA CHMP summary of 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 is based on results from the phase III multi-regional clinical trials in patients with plaque psoriasis (NCT04785326).

The approval of Imuldosa® (ustekinumab biosimilar) further enhances Accord Healthcare's biosimilar portfolio and strengthens Accord presence in Autoimmune therapy area.

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