AJMC December 2, 2024
Key Takeaways
- Yesintek, a Stelara biosimilar, received FDA approval for IBD, plaque psoriasis, and psoriatic arthritis, with a launch expected in late 2025.
- Clinical trials confirmed Yesintek’s equivalence to Stelara in efficacy, safety, immunogenicity, and pharmacokinetics.
- Psoriatic arthritis affects 6 to 25 per 100,000 people in the US, while plaque psoriasis affects 1% to 2% of the population.
- Inflammatory bowel disease impacts 2.4 to 3.1 million Americans, with annual health care costs reaching $8.5 billion.
The approval of Yesintek (ustekinumab-kfce), the sixth biosimilar to reference Stelara, will be used to treat patients with various immunology conditions, including psoriatic arthritis and inflammatory bowel disease.
This article was originally published by The Center for Biosimilars®.
The FDA has approved Yesintek...
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