South Korean company Dong-A ST wins FDA approval for Stelara biosimilar
- Dong-A ST, a South Korean company, has received FDA approval for Imuldosa, a biosimilar of Johnson & Johnson's Stelara, marking a significant milestone in its global biosimilar market expansion.
- Imuldosa was developed in collaboration with Meiji Seika Pharma and will be commercialized by Intas Pharmaceuticals, with the process involving a complex series of agreements and regulatory approvals.
- The approval of Imuldosa represents a growing trend in the pharmaceutical market, where biosimilars are becoming more prevalent to reduce healthcare costs, with various other Stelara biosimilars entering the market and affecting its revenue projections.
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In a significant milestone for the pharmaceutical industry, South Korean company Dong-A ST has secured approval from the U.S. Food and Drug Administration (FDA) for its Stelara biosimilar, Imuldosa. This approval marks a major achievement for Dong-A ST, solidifying its position as a major player in the global biosimilar market. Imuldosa is the latest FDA-approved biosimilar of Johnson & Johnson’s (J&J) blockbuster therapy for the treatment of certain autoimmune diseases.
A Breakthrough in Biosimilar Development
The approval of Imuldosa is a testament to the company's rigorous research and development efforts. Developed jointly by Dong-A ST and Meiji Seika Pharma, Imuldosa is a biosimilar referencing Stelara, a highly successful biologic used to treat conditions like plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
Stelara, developed by Janssen Biotech Inc., is one of the highest-grossing biopharmaceuticals globally, with sales reaching $10.86 billion in 2023. The patent for Stelara's formulation expired in September 2023, paving the way for biosimilar development and competition in the market.
The Road to Approval
The journey to FDA approval for Imuldosa was long and complex. The rights for research and development and commercialization were transferred from Dong-A Socio Holdings to Dong-A ST in July 2020, enhancing project management and efficiency. The following year, Dong-A ST and Meiji Seika Pharma entered into a global license agreement with Intas Pharmaceuticals, which will commercialize the biosimilar through its global subsidiaries, including Accord BioPharma in the U.S. and Accord Healthcare in the European Union, U.K., and Canada.
In October 2023, Dong-A ST submitted a biologics license application (BLA) for Imuldosa, which was subsequently accepted by the FDA. After a thorough review process, the FDA granted approval for Imuldosa on October 11, 2024.
Implications for the Pharmaceutical Market
The approval of Imuldosa signals a significant shift in the pharmaceutical market. With several other biosimilars already approved or in the pipeline, the competition for Stelara is set to intensify. Amgen’s Wezlana, for instance, was the first biosimilar of Stelara to be approved but will not be available for purchase until January 1, 2025, following a patent dispute settlement with J&J. Samsung Bioepis’s Pyzchiva and Alvotech's Selarsdi also recently received FDA approvals, further expanding the biosimilar landscape.
The entry of these biosimilars is expected to lead to a gradual decline in Stelara’s revenue. Forecasts suggest that Stelara’s sales may drop from $10 billion in 2024 to $7.1 billion in 2025 and $5.2 billion in 2026, according to GlobalData.
The Future of Biosimilars
The approval of Imuldosa underscores the growing importance of biosimilars in addressing healthcare costs and enhancing patient access to treatment. Biosimilars are biologic medications that are highly similar to reference biologic products, with no clinically meaningful differences in terms of safety and efficacy.
In the U.S., biosimilars have been gaining traction due to their potential to reduce healthcare expenditures. The Centers for Medicare and Medicaid Services (CMS) has also begun to prioritize biosimilars in its drug price negotiation program, aiming to make these affordable alternatives more accessible to patients.
Conclusion
The FDA approval of Imuldosa marks a significant milestone in the pharmaceutical industry, demonstrating Dong-A ST’s commitment to innovative research and development. As the market continues to evolve, it is clear that biosimilars will play a crucial role in shaping the future of healthcare. With several more biosimilars poised to enter the market, it will be interesting to see how this competition shapes the landscape of autoimmune disease treatments.
Dong-A ST’s achievement is not only a testament to its prowess in R&D but also signals a new era in biosimilar development. As the company looks to introduce Imuldosa in the U.S. market, it is poised to make a substantial impact on the global pharmaceutical stage.
References
- Dong-A ST Achieves U.S. FDA Approval for Stelara Biosimilar: Dong-A ST has achieved a significant milestone with the U.S. FDA approval of its Stelara biosimilar, IMULDOSA, marking a pivotal moment in ...
- US FDA Approves Dong-A ST’s IMULDOSA™ (ustekinumab-srlf), a Biosimilar to STELARA: Dong-A ST announced on October 11 that Imuldosa™ (ustekinumab-srlf/DMB-3115), a biosimilar referencing Stelara®, has won U.S. Food and Drug Administration (FDA) approval.
- FDA Approves Imuldosa, a Biosimilar to Stelara: The FDA has approved Imuldosa (ustekinumab-srlf), a biosimilar referencing Stelara (ustekinumab), for the treatment of autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
