On 19 May 2025, Formycon and Fresenius Kabi announced that the US FDA has designated FYB202/Otulfi® (ustekinumab-aauz) as interchangeable with J&J/Janssen’s Stelara® (ustekinumab) in all presentations of the reference product.
FYB202/Otulfi® was developed by Formycon and was approved in the US and Europe in September 2024. It is being commercialised in the US, Canada and most of Europe by Fresenius Kabi, under a global licence agreement entered into between Formycon and Fresenius in February 2023.
In August 2023, Formycon and Fresenius reached a settlement with J&J in the US enabling US launch of FYB202/Otulfi® “no later than 15 April 2025”. FYB202/Otulfi® was the fourth ustekinumab biosimilar to be launched in the US in early March 2025.
Amgen’s Wezlana® was the first ustekinumab biosimilar to be approved as interchangeable with Stelara® in the US on October 2023, followed by Alvotech/Teva’s Selarsdi® in early May 2025.