• Accord Healthcare Limited has received a positive recommendation from the EMA's CHMP for Imuldosa (DMB-3115), a biosimilar of the immunology drug Stelara® (ustekinumab).
  • The positive opinion is backed by a phase III clinical trial demonstrating that DMB-3115 is comparable in efficacy and safety to Stelara.

Accord Healthcare Limited, a subsidiary of Intas Pharmaceuticals, has announced a significant development in its biosimilars portfolio. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorization for Imuldosa (development code: DMB-3115), a biosimilar of Stelara (ustekinumab), which is marketed by Janssen Biotech Inc., a subsidiary of Johnson & Johnson.

Ustekinumab is a human monoclonal antibody that targets interleukin-12 and interleukin-23, two cytokines involved in inflammatory and immune responses. This makes it a critical treatment option for various immune-mediated inflammatory diseases.

Paul Tredwell, Executive Vice President of Accord Healthcare, expressed enthusiasm about the CHMP's recommendation, stating:

"We are delighted with the positive CHMP opinion for Imuldosa. This further strengthens our established autoimmune franchise, where Accord already has several leading specialty brands."

He emphasized that this endorsement aligns with Accord's ongoing strategy to expand its specialty business, highlighting a robust portfolio that now includes a total of ten biosimilars in development.

"This positive opinion reaffirms our commitment to improve access to value-based medicines for patients," added Tredwell.

The EMA's positive opinion is based on comprehensive data demonstrating that DMB-3115 is highly similar to Stelara. According to the submission for marketing authorization, results from a phase III multi-regional clinical trial in patients with plaque psoriasis (NCT04785326) have shown comparable efficacy and safety profiles between DMB-3115 and the reference product, Stelara.

Stelara has been successful in treating various immunology indications and has generated impressive global sales of approximately $19 billion, with $3.2 billion of that total attributed to sales in Europe, as reported by IQVIA data for the period ending June 2024.

The positive CHMP opinion marks a crucial step toward making Imuldosa available to patients across Europe, further advancing Accord's mission to enhance the accessibility of high-quality, value-based treatments.

Edited by Harshajit Sarmah