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FDA Approves First Stelara Biosimilar

On October 31, 2023, the U.S. Food and Drug Administration (FDA) approved Wezlana™ (ustekinumab-auub) injection manufactured by Amgen. This is the first approved biosimilar to Stelara®  (ustekinumab) injection manufactured by Janssen Biotech – Wezlana™ is also interchangeable. In states where pharmacy regulations allow substitution, it can be dispensed instead of Stelara® without contacting the prescriber. Ustekinumab is used to treat adults who have active Crohn’s disease (CD) or ulcerative colitis (UC), psoriatic arthritis (PsA) or plaque psoriasis. Under a settlement agreement, Wezlana™ can be launched in the U.S. at any time before January 1, 2025. Additional biosimilars to Stelara® are expected to launch in 2025. U.S. sales for Stelara® amounted to approximately $6.4 billion in 2022.

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https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases

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