Accord Healthcare Receives Approval for Imuldosa®
Accord Healthcare Limited has exciting news with the European Commission granting marketing authorization for Imuldosa® (development code: DMB-3115), a biosimilar to Stelara® (ustekinumab). This drug is crucial for treating various immune-mediated inflammatory diseases.
Details of the European Commission Approval
The recent approval from the EC follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). This authorization covers all EU member states, plus Iceland, Norway, and Liechtenstein, highlighting the significant impact of this decision.
Extensive Clinical Trials
The CHMP's backing was based on a comprehensive and detailed set of data showcasing both analytical and clinical similarities between DMB-3115 and Stelara®. This includes results from a multi-regional phase III trial focused on patients with plaque psoriasis, where DMB-3115 demonstrated therapeutic equivalence to Stelara®, ensuring a comparable safety profile.
Market Potential and Commercialization
With the marketing authorization secured, the entry of Imuldosa® into the EU market is noteworthy due to the estimated value of the ustekinumab market, which stands at approximately €2.9 billion (around US$3.18 billion), as reported by IQVIA's June 2024 data. This development opens up significant commercial opportunities for Accord Healthcare within a burgeoning market.
Global Licensing Rights
Under an exclusive licensing agreement, Intas Pharmaceuticals will manage the commercialization of Imuldosa® worldwide, with specific exceptions for Japan, Korea, and certain regions in Asia. Additionally, it's worth noting that Imuldosa® received approval from the USFDA recently, further expanding its availability.
About Ustekinumab and Its Significance
Ustekinumab is classified as a human monoclonal antibody, effectively targeting interleukin-12 and interleukin-23, cytokines integral to inflammatory and immune responses. Stelara®, its branded counterpart, has a large global footprint, with reported sales peaking around US$19 billion globally, of which US$3.2 billion stemmed from Europe, according to the latest IQVIA figures.
Future Aspirations in Autoimmunity
Joe Dunford, the VP of Specialty Brands at Accord, expressed enthusiasm regarding this milestone, stating that Accord is committed to becoming a leading entity in the autoimmune sector. The approval of Imuldosa® represents the fifth biosimilar authorized in Europe for Accord. They aspire to launch a total of 20 biosimilars by the year 2030, expanding access to high-quality treatments for patients.
Frequently Asked Questions
What is Imuldosa®?
Imuldosa® is a biosimilar to Stelara® (ustekinumab), intended for the treatment of various immune-mediated inflammatory diseases.
What approval did Accord Healthcare recently obtain?
Accord Healthcare received marketing authorization from the European Commission for Imuldosa®, allowing its entry into the EU market.
How does Imuldosa® compare to Stelara®?
Imuldosa® has demonstrated therapeutic equivalence to Stelara® based on extensive clinical trials, ensuring a similar safety profile.
What is the market potential for ustekinumab?
The estimated value of the ustekinumab market in Europe is approximately €2.9 billion (US$3.18 billion).
What are Accord's future plans?
Accord aims to launch a total of 20 biosimilars by 2030, advancing its pipeline in the autoimmune treatment sector.
