On 27 September 2024, Formycon and Fresenius Kabi announced that Otulfi®/FYB202, biosimilar to Janssen’s Stelara® (ustekinumab), has received approval from both the European Commission and the US FDA. The European approval is for moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis and active psoriatic arthritis, while the US approval is for the same indications with the addition of ulcerative colitis.
Otulfi®/FYB202 is being commercialised in the US 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 March 2024 Formycon and Fresenius announced they reached a settlement with J&J/Janssen regarding the commercialisation of FYB202 in Europe and Canada. This followed a US settlement in August 2023, enabling US launch of FYB202 “no later than 15 April 2024”.
Ustekinumab biosimilars previously approved in Europe are Samsung Bioepis’ Eksunbi™ (September 2024), Celltrion’s SteQeyma®/CT-P47 (August 2024), Amgen’s Wezenla™ (June 2024), Sandoz/Samsung Bioepis’ Pyzchiva®/SB17 (April 2024, launched July 2024), and Alvotech/Stada’s Uzpruvo® (January 2024, launched July 2024). Bio-Thera’s MAA for BAT2206 (ustekinumab) was accepted by the EMA in July 2024.
In the US, approved ustekinumab biosimilars are Samsung Bioepis’ Pyzchiva®/SB17 (July 2024), Alvotech/Teva’s Selarsdi™ (April 2024) and Amgen’s Wezlana® (October 2023). Further approvals and are anticipated in light of J&J/Janssen’s ustekinumab settlements with Biocon (BLA for Bmab 1200 accepted May 2024, US launch dated no later than 22 February 2025), Accord BioPharma (BLA for DMB-3115 accepted January 2024, US launch date no later than 15 May 2025) and Celltrion (application submitted with the FDA for CT-P43 in June 2023, US launch date of 7 March 2025).