Posted by Michael Wonder on 30 Nov 2023
Formycon and Fresenius Kabi announce file acceptance for FYB202, a biosimilar candidate to Stelara (ustekinumab), by the US FDA
30 November 2023 - Formycon and its commercialisation partner Fresenius Kabi today announced that the US FDA has accepted the biologics license application for FYB202, a proposed biosimilar candidate to Stelara.
The reference medicinal product Stelara is approved for treatment of moderate to severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis.
