FDA approves interchangeability of Formycon and Fresenius Kabi Stelara copy
Formycon (FSE: FYB) and its commercialization partner Fresenius Kabi (ETR: FRE) have announced that the US Food and Drug Administration (FDA) has designated FYB202/Otulfi (ustekinumab-aauz) as interchangeable with Johnson & Johnson’s (NYSE: JNJ) reference biologic Stelara (ustekinumab).
As of now, Otulfi is interchangeable in all presentations matching the reference product.
It was initially approved by the FDA in September 2024 for the treatment of the same conditions as Stelara, namely moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.
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