On September 27, 2024, Formycon AG (“Formycon”) and its commercialization partner Fresenius Kabi (“Fresenius”) jointly announced that the European Commission (EC) has issued a marketing authorization for FYB202/OTULFI™ (ustekinumab-aauz), a biosimilar to STELARA®. FYB202/OTULFI™ is an interleukin-12 and interleukin-23 antibody and was approved for moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis, and active psoriatic arthritis in Europe. Dr. Stefan Glombitza, CEO of Formycon AG, said: “FYB202/ustekinumab is our second biosimilar with market approval in Europe . . . Chronic inflammatory diseases are globally on the rise and negatively impact the quality of life of millions of people. This especially relates to Europe, which has the highest prevalence of psoriatic diseases in the world. With FYB202/OTULFI we are – together with our partner Fresenius Kabi – committed to providing a safe, effective and cost-efficient treatment option for this large number of patients.”
On September 30, 2024, Formycon and Fresenius also announced that OTULFI™ received FDA approval for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Management Board, noted that “[t]he FDA approval of OTULFI™, Fresenius Kabi’s fourth biosimilar product in the U.S. market, is an important milestone on our pathway to consistently broadening our biopharma portfolio in the U.S. and worldwide.” OTULFI™ is the fourth STELARA® biosimilar approved in the United States, following Amgen’s WEZLANA™ (approved in October 2023), Alvotech’s and Teva’s SELARSDI™ (approved in April 2024), and Samsung Bioepis’s PYZCHIVA® (approved in July 2024).