Formycon and Fresenius Kabi announce EMA acceptance of the marketing authorisation application for FYB202, an ustekinumab biosimilar candidate

Formycon

29 September 2023 - Formycon and its commercialisation partner Fresenius Kabi today announced that the EMA has accepted the marketing authorisation 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.

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Michael Wonder

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Michael Wonder

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Medicine , Europe , Biosimilar , Dossier