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

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

Accord Healthcare announced 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, a biosimilar of Stelara (ustekinumab), marketed by Janssen Biotech, 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 commercialisation rights for DMB-3115, excluding Korea, Japan, and certain Asian countries.

Intas Pharmaceuticals plans to commercialise DMB-3115 through its global subsidiaries, Accord BioPharma in the US and Accord Healthcare in the EU, the 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 $D 3.2 billion sales came from Europe as per IQVIA MAT Jun'24 data.

"We are 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 Binish Chudgar, Executive Chairman and Managing Director, Intas Pharmaceuticals.

Paul Tredwell, Executive Vice President of Accord Healthcare said, " We are delighted with the positive CHMP opinion for Imuldosa, a biosimilar to Ustekinumab. The recommendation affirms the robust scientific approach behind our goal of broadening access to high-quality biological 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."