Fresenius Kabi and Formycon AG announced they reached a settlement in the US with Johnson & Johnson relating to their ustekinumab (FYB202), biosimilar to Stelara®. As part of the agreement, Fresenius and Formycon can launch in the US “no later than 15 April 2025”. There were no proceedings on foot between the parties on foot in relation to FYB202 at the time of the settlement.
On 25 April 2023, Formycon announced the successful conclusion of its extended Phase I clinical study comparing the pharmacokinetics of FYB202 to Stelara®. Formycon expects to file its BLA for FYB202 with the FDA later in 2023.
This settlement follows Johnson & Johnson’s previous settlement agreements with Amgen (for a licensed entry date no later than 1 January 2024), and with Alvotech and Teva (for a licensed entry date for AVT04 in the US no later than 21 February 2025).