Imuldosa snags FDA approval as fifth Stelara biosimilar in mounting market logjam
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Key takeaways:
- Imuldosa, an ustekinumab biosimilar, is approved for multiple inflammatory diseases, including Crohn’s disease and ulcerative colitis.
- The drug is expected to be available in the U.S. in early 2025.
The FDA has approved the Stelara biosimilar, Imuldosa, for Crohn’s disease, ulcerative colitis and all other indications of the reference product, and the latest addition to the Stelara biosimilar bottleneck set to release in 2025.
Imuldosa (ustekinumab-srlf; Intas Pharmaceuticals, Accord Biopharma) is now the fifth FDA-approved biosimilar for Stelara (ustekinumab, Janssen) to enter the chronic inflammatory diseases market following the recent approval of Otulfi (ustekinumab-aauz; Fresenius Kabi, Formycon AG) in September. However, to date, none of these biosimilars have been launched in the U.S. market as Stelara remains patent-protected until early 2025.
The drug was first developed by Dong-A Socio Holdings and Meiji Seika Pharma and, through a licensing agreement in 2021, Intas Pharmaceuticals acquired commercial rights. Accord Biopharma, a global subsidiary of Intas, is expected to launch Imuldosa in the U.S.
“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,” Binish Chudgar, executive chairman of the board at Intas Pharmaceuticals, said in the press release. “It is Accord BioPharma’s goal to go beyond biology and continuously work to provide affordable world class treatments to the patients. As our presence in the biosimilar market continues to grow, so does our commitment to offering high quality, affordable and effective alternatives to reference drugs to the patients in need.”
According to the company, the agency based its decision “on a comprehensive clinical development program” which demonstrated that the drug was “similar to its reference product Stelara in terms of pharmacokinetic characteristics, safety, tolerability and efficacy.”
Indications for Imuldosa include moderately-to severely active Crohn’s disease, moderately-to severely active ulcerative colitis, moderate-to severe plaque psoriasis and active psoriatic arthritis in adults. The drug is also approved for pediatric patients with moderate-to-severe plaque psoriasis and active PsA.
“For Accord BioPharma, this is another step forward in our efforts to deliver affordable treatments and satisfy patient needs,” Chrys Kokino, U.S. president of Accord, said. “The approval of Imuldosa, our second biosimilar, is evidence of our growing momentum in the industry and our leadership in supporting families with accessible options to address urgent and critical medical conditions.”
Intas Pharmaceuticals noted Imuldosa is expected to launch within the first half of 2025.
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