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Accord Healthcare Receives Marketing Authorization for Imuldosa®

Accord Healthcare Limited recently announced that the European Commission (EC) has granted marketing authorization for Imuldosa® (development code: DMB-3115), a biosimilar to the well-known drug Stelara® (ustekinumab). This biosimilar is specifically indicated for treating a variety of immune-mediated inflammatory diseases. The authorization follows a favorable opinion issued on 19 October 2024 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and it covers all 27 member states of the European Union, as well as Iceland, Norway, and Liechtenstein.

The approval from the CHMP was based on extensive analytical, clinical, and non-clinical data which included results from a multi-regional phase III clinical trial focusing on patients with plaque psoriasis. This study demonstrated that DMB-3115 achieved therapeutic equivalence with Stelara® in its primary outcomes, while also exhibiting a comparable safety profile.

The significance of this marketing authorization cannot be overstated, as it opens the door for Imuldosa® to enter a lucrative ustekinumab market in Europe, which is estimated to be valued at approximately €2.9 billion (US$3.18 billion) according to IQVIA data from June 2024. Additionally, the demand for effective treatments in this therapeutic area is more crucial than ever as the global population ages and the prevalence of autoimmune diseases rises.

Accord Healthcare, under the umbrella of Intas Pharmaceuticals, has secured exclusive rights to commercialize Imuldosa® globally, excluding regions like Japan, Korea, and a few other Asian nations. Importantly, the drug had already received approval from the US FDA on October 10, 2024, indicating a strong commitment to provide high-quality therapeutic options in major pharmaceutical markets.

Ustekinumab, the active ingredient in Stelara®, is a human monoclonal antibody that targets pro-inflammatory cytokines interleukin-12 and interleukin-23, key players in the immune response. Stelara® has been a cornerstone in treating various inflammatory diseases, boasting global sales that topped US$19 billion, with sales in Europe contributing roughly US$3.2 billion as reported in the latest IQVIA data.

Joe Dunford, VP of Specialty Brands at Accord, emphasized the company's dedication to becoming a significant contender in the autoimmune market. He mentioned, "We are thrilled that the European Commission has approved Imuldosa®. This achievement ensures that patients across Europe and beyond have access to quality biosimilars. We are focused on advancing our pipeline, targeting the launch of 20 biosimilars by the year 2030."

Future Outlook

The approval of Imuldosa® marks a substantial milestone for Accord Healthcare as it continues its innovative journey in the pharmaceutical landscape. The company's strategic approach to developing biosimilars not only broadens the treatment choices available to patients but also fosters healthy competition in the market, driving down costs and improving access to life-saving therapies. As Accord eyes the future, the progression towards its ambitious goal of launching multiple biosimilars by 2030 reflects its commitment to reshaping the treatment paradigm for autoimmune conditions.

In conclusion, the approval of Imuldosa® is a promising development that supports Accord’s mission to provide high-quality, affordable therapeutic options to patients suffering from immune-mediated inflammatory diseases. With a strong pipeline and future plans for expansion, Accord Healthcare is set to make a significant impact in the healthcare industry, offering hope and improved outcomes for many patients worldwide.