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Fresenius And Formycon File Ustekinumab In US

Firms Submit BLA For FYB202 Stelara Biosimilar To FDA; Launch Anticipated In April 2025

 
• By Dave Wallace

Partners Fresenius Kabi and Formycon have submitted a US filing for their FYB202 ustekinumab biosimilar rival to Stelara.

Sign outside of FDA's headquarters in White Oak, MD
Fresenius Kabi and Formycon have submitted their filing to the FDA • Source: Alamy

Fresenius Kabi and Formycon have announced that the US Food and Drug Administration has accepted their filing for a biosimilar rival to Stelara (ustekinumab).

The news follows a recent filing for the pair’s FYB202 version in Europe

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