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."