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FDA Approves Stelara Biosimilar, Selarsdi for Subcutaneous Use hero image

FDA Approves Stelara Biosimilar, Selarsdi for Subcutaneous Use

On April 16, 2024, the FDA approved Selarsdi (ustekinumab-aekn) for subcutaneous (SC) use as a biosimilar referencing Stelara (ustekinumab). Selarsdi is approved for only two of the indications that Stelara currently has approval for: the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis. Some key differences between Wezlana, the first biosimilar approved for reference product Stelara in 2023 and Selarsdi, are that the FDA granted Wezlana an interchangeability designation and Wezlana is approved as both SC and intravenous (IV) formulations. Wezlana is also approved for the same indications as Stelara: plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Selarsdi is expected to be marketed in the U.S. no later than February 21, 2025, due to a settlement agreement with Stelara’s manufacturer, Johnson & Johnson and Teva/Alvotech. Under a settlement agreement, Wezlana can be launched in the U.S. at any time before January 1, 2025.

https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2024/Alvotech-and-Teva-Announce-U.S.-FDA-Approval-of-SELARSDI-ustekinumab-aekn-biosimilar-to-Stelara-ustekinumab/default.aspx

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