On 3 March 2025, Fresenius announced the US launch of Otulfi®/FYB202 (ustekinumab-aauz), biosimilar to J&J/Janssen’s Stelara®.
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. Under the agreement, Fresenius has exclusive commercialisation rights to the ustekinumab biosimilar in key global markets, while Formycon retains semi-exclusive commercialisation rights in Germany, parts of the MENA region and Latin America.
In August 2023, Formycon and Fresenius reached a settlement with J&J in the US enabling US launch of FYB202 “no later than 15 April 2025”. This was followed by a settlement in March 2024 regarding the commercialisation of FYB202/Otulfi® in Europe and Canada. The agreed launch dates for FYB202 in the UK and Canada remain confidential.
The US launch of Otulfi® follows those of Sandoz’s Pyzchiva® and Biocon’s Yesintek™ on 24 February 2025, Alvotech/Teva’s Selarsdi® on 21 February 2025 and Amgen’s Wezlana® in early January 2025 (through Optum Health Solution’s private label subsidiary Nuvaila).