Fresenius Kabi

Fresenius Kabi and Formycon receive FDA approval for Otulfi, a Stelara biosimilar, for treating Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. Otulfi is the fourth Stelara biosimilar approved in the US, following Amgen’s Wezlana, Alvotech and Teva’s Selarsdi, and Samsung Bioepis and Sandoz’s Pyzchiva. Stelara sales are expected to drop to $1.2bn by 2030 due to biosimilar competition.

Fresenius Kabi and Formycon AG announced FDA approval of Otulfi™, a ustekinumab biosimilar referencing Stelara®, for treating Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. Otulfi™ is Fresenius Kabi’s fourth biosimilar in the U.S., expanding its immunology and oncology portfolio.

Fresenius Kabi and Formycon AG announced FDA approval of Otulfi™ (ustekinumab-aauz), a ustekinumab biosimilar referencing Stelara®, for treating Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. This marks Fresenius Kabi's fourth biosimilar in the U.S., aligning with their Vision 2026 growth strategy to expand their biopharma portfolio globally.

FDA approves Otulfi, a fourth Stelara biosimilar, for chronic inflammatory diseases including Crohn’s and ulcerative colitis, expected to be available in the U.S. by February.

FDA approves ustekinumab-aauz (Otulfi), the fourth ustekinumab biosimilar referencing Stelara, for Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. Otulfi, developed by Formycon and Fresenius Kabi, was also approved by the European Commission. Due to settlements, Otulfi and other ustekinumab biosimilars will launch no earlier than February 22, 2025.

Formycon and Fresenius Kabi receive FDA approval for FYB202/Otulfi™ (ustekinumab-aauz), a biosimilar to Stelara®, for treating Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. This marks Formycon's third successful FDA approval for a biosimilar, with Fresenius Kabi set to market Otulfi™ in the US by February 22, 2025, under a patent settlement with Johnson & Johnson.

Formycon and Fresenius Kabi announce FDA approval of FYB202/OtulfiTM (ustekinumab-aauz), a biosimilar to Stelara®, for treating Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. This marks Formycon’s third successful FDA approval for a biosimilar, with Fresenius Kabi set to market OtulfiTM in the US by February 2025.