FDA approves Yesintek, sixth Stelara biosimilar; launch slated for February
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The FDA has approved the Stelara biosimilar Yesintek for indications matching the reference product, with a commercial launch date expected for early 2025, according to a press release from Biocon Biologics.
Yesintek (ustekinumab-kfce, Biocon) is approved for psoriatic arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis. It is the sixth approved biosimilar for Stelara (ustekinumab, Janssen).
This latest biosimilar is expected to launch in the United States no later than Feb. 22, as per a settlement and licensing agreement signed earlier this year between Janssen and Biocon Biologics, a subsidiary of Biocon Ltd, according to the release.
The approval follows that of Imuldosa (ustekinumab-srlf; Intas Pharmaceuticals, Accord Biopharma), the fifth Stelara biosimilar, in October. Patents for ustekinumab began expiring in 2023, but no biosimilars will be released in the United States until 2025 due to settlement and license agreements.
Stelara is one of several drugs set to be discounted for Medicare users in 2026 as a result of federal drug price negotiations. A 30-day supply will be discounted 66% from its 2023 list price, falling from $13,836 to $4,695, according to the White House.
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