On 15 January 2025, Formycon and Fresenius Kabi announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB202/Otulfi®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), for moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.
This closely follows the Canadian approval of both subcutaneous and intravenous formulations of FYB202/Otulfi® on 8 January 2025, for the same indications.
FYB202/Otulfi® was approved in Europe and the US 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. 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 March 2024, Formycon and Fresenius announced they reached a settlement with J&J/Janssen regarding the commercialisation of FYB202/Otulfi® in Europe and Canada. This followed a US settlement in August 2023, enabling US launch of FYB202 “no later than 15 April 2025”. The agreed launch dates for FYB202 in the UK and Canada remain confidential.