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Formycon And Fresenius Kabi Receive FDA Approval For Fyb202/ Otulfitm



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Sept 30 (Reuters) -FORMYCON AG FYB.DE:

  • AND FRESENIUS KABI RECEIVE FDA APPROVAL FOR FYB202/ OTULFITM(USTEKINUMAB-AAUZ)

  • TULFITMRECEIVED FDA APPROVAL FOR BOTH SUBCUTANEOUS AND INTRAVENOUS FORMULATIONS, TO TREAT SAME CONDITIONS AS STELARA®

  • APPROVAL REPRESENTS THIRD SUCCESSFUL FDA APPROVAL FOR A FORMYCON BIOSIMILAR, TWO OF THEM IN 2024

  • IN ACCORDANCE WITH PATENT SETTLEMENT BETWEEN FORMYCON, FRESENIUS KABI AND JOHNSON & JOHNSON, FRESENIUS KABI HAS RIGHT TO MARKET OTULFITM IN US NO LATER THAN FEBRUARY 22, 2025

  • OTULFITMRECEIVED FDA APPROVAL FOR BOTH SUBCUTANEOUS AND INTRAVENOUS FORMULATIONS, TO TREAT SAME CONDITIONS AS STELARA®

  • STELARA® GLOBAL SALES EXCEEDED USD 10 BILLION IN 2023

  • FYB202 SHOWS COMPARABLE EFFICACY TO STELARA® IN PSORIASIS

Source text for Eikon: ID:nEQ1ZDpvCa

Further company coverage: FYB.DE


(Gdansk Newsroom)

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