Accord’s Stelara biosimilar Imuldosa wins positive CHMP recommendation

The fully-owned Intas Pharmaceuticals subsidiary Accord Healthcare has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for Imuldosa.

This product is a biosimilar of Johnson & Johnson’s (NYSE: JNJ) Stelara (ustekinumab), a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23, which may play an important role in inflammatory and immune responses.

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."

Binish Chudgar, executive chairman and managing director of Intas Pharmaceuticals, added: “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.”

According to the EMA CHMP positive opinion, Imuldosa is highly similar to Stelara and has demonstrated comparable quality, safety and efficacy to the reference product. 

The Marketing Authorization Application submission for Imuldosa includes results from the Phase III multi-region trial in patients with plaque psoriasis. The study demonstrated a comparable efficacy and safety profile between the biosimilar product and Stelara.

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