The FDA has granted approval to Imuldosa (ustekinumab-srlf), a biosimilar referencing Stelara (ustekinumab), for the treatment of several chronic inflammatory conditions. These include Crohn’s disease, ulcerative colitis, moderate-to-severe plaque psoriasis, and active psoriatic arthritis in both adult and pediatric patients. The approval, announced by Accord BioPharma, a U.S. specialty division of Intas Pharmaceuticals, marks a significant step toward providing more affordable treatment options for millions of Americans suffering from these conditions.
Clinical Equivalence and Comprehensive Development
The FDA's decision was based on a comprehensive clinical development program that demonstrated Imuldosa's similarity to Stelara in terms of pharmacokinetic characteristics, safety, tolerability, and efficacy. According to Accord BioPharma, the data confirmed that Imuldosa adheres to the FDA's current biosimilar guidelines. This rigorous evaluation process ensures that Imuldosa offers the same clinical benefits as its reference product, providing confidence for both healthcare providers and patients.
Addressing Unmet Needs in Inflammatory Diseases
Chronic inflammatory conditions significantly impact the quality of life, emotional well-being, and self-image of affected individuals. Stelara, developed by Janssen Biotech, has been a leading treatment for these conditions, achieving global sales of $10.86 billion in 2023. However, its high cost has limited accessibility for many patients. The introduction of Imuldosa as a biosimilar aims to address this unmet need by offering a more affordable alternative while maintaining the same therapeutic benefits.
Market Dynamics and Future Availability
While Imuldosa is now the fifth FDA-approved biosimilar for Stelara, it is not yet available on the U.S. market. Due to patent protection, the launch is anticipated in the first half of 2025. This delay underscores the complexities of the biosimilar market, where patent litigation and regulatory hurdles can impact market entry. Once launched, Imuldosa is expected to compete with other approved biosimilars, potentially driving down costs and increasing patient access.
Statements from Key Stakeholders
"For Accord BioPharma, this is another step forward in our efforts to deliver affordable treatments and satisfy patient needs," said Chrys Kokino, U.S. president of Accord. Binish Chudgar, executive chairman of the board at Intas Pharmaceuticals, added, "We're proud to add Imuldosa to our U.S. biosimilar portfolio, which represents an affordable treatment option for patients living with painful inflammatory conditions."
Development and Commercialization
Imuldosa was initially developed as DMB-3115 by Dong-A Socio Holdings and Meiji Seika Pharma. In 2021, Intas Pharmaceuticals acquired exclusive commercialization rights through a licensing agreement. Accord BioPharma, as a global subsidiary of Intas, will oversee the U.S. commercialization of Imuldosa. This collaborative effort highlights the global nature of pharmaceutical development and the importance of partnerships in bringing biosimilars to market.
CHMP Recommends Approval in Europe
In addition to the FDA approval in the U.S., Dong-A ST announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has issued a positive opinion for Imuldosa. Accord Healthcare, a subsidiary of Intas Pharmaceuticals and Dong-A ST’s partner, submitted the Marketing Authorisation Application (MAA) to the EMA in June 2023. The CHMP's recommendation plays a crucial role in the final decision by the European Commission (EC), which will determine the official marketing authorization.
Implications for Healthcare
The approval of Imuldosa and the positive CHMP opinion represent significant milestones in the effort to provide more accessible and affordable treatment options for chronic inflammatory diseases. As more biosimilars enter the market, healthcare systems may see reduced costs, allowing for greater investment in other areas of patient care. Patients, in turn, may benefit from increased access to effective therapies, improving their overall health and quality of life.
