Fresenius Kabi

FDA approves ustekinumab-aauz (Otulfi) for Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. The approval is based on data showing comparable efficacy and safety to Stelara. Additionally, the FDA grants Orphan Drug Designation to navenibart (STAR-0215) for hereditary angioedema and Rare Pediatric Disease Designation to MDL-101 for congenital muscular dystrophy type 1a.

Fresenius Kabi and Formycon AG received FDA approval for Otulfi (ustekinumab-aauz), a biosimilar of 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. market, aligning with their Vision 2026 strategy to expand their biopharma portfolio globally.

Teva Pharmaceuticals and mAbxience announce global licensing agreement for anti PD-1 oncology biosimilar candidate, with mAbxience leading development and production, and Teva managing regulatory approvals and commercialization in Europe and the U.S.

FDA approves Fresenius Kabi’s and Formycon’s Otulfi, a biosimilar to Stelara, for treating Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. This marks Fresenius Kabi’s fourth biosimilar approval by the FDA, aligning with its Vision 2026 strategy to expand its biopharma market presence.

FDA approved Fresenius Kabi and Formycon's Otulfi™ (ustekinumab-aauz) as the fourth biosimilar of Janssen/Johnson & Johnson’s Stelara® (ustekinumab) on September 27, 2024, following Amgen’s Wezlana™, Alvotech/Teva’s Selarsdi™, and Samsung Bioepis/Sandoz’s Pyzchiva®. Otulfi™ received EU approval on the same day. Under settlement agreements, Otulfi™, Wezlana™, Selarsdi™, and Pyzchiva® can enter the U.S. market by February 2025. Numerous Stelara® biosimilars await FDA approval, with no pending patent disputes.

FDA approves Fresenius Kabi and Formycon's Otulfi (ustekinumab-aauz), a ustekinumab biosimilar to Stelara, for treating Crohn’s disease, moderate to severe plaque psoriasis, ulcerative colitis, and active psoriatic arthritis. Otulfi is available as subcutaneous and intravenous formulations, not indicated for hypersensitivity to ustekinumab.

Fresenius Kabi and Formycon receive FDA approval for Otulfi, a biosimilar to J&J's Stelara, indicated for Crohn's disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. Otulfi is Fresenius Kabi's fourth biosimilar in the US, supported by comprehensive data showing comparable efficacy, safety, pharmacokinetics, and immunogenicity to Stelara.

FDA approves Stelara biosimilar Otulfi (ustekinumab-aauz) for Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. Otulfi, available in subcutaneous and intravenous formulations, targets interleukin-12 and interleukin-23. It will launch in the U.S. by Feb. 22, 2025, and is also approved in the EU. Common adverse reactions include nasopharyngitis, upper respiratory tract infection, headache, and fatigue.

The FDA approved ustekinumab-aauz (Otulfi; Fresenius Kabi) as a biosimilar to ustekinumab (Stelara; Johnson and Johnson), indicated for Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. Otulfi targets cytokines IL-12 and IL-23, crucial in inflammatory and immune responses.

FDA approves Otulfi™ (ustekinumab-aauz), a biosimilar to Stelara®, for treating moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn disease or ulcerative colitis. Approval based on phase 3 VESPUCCI study showing comparable efficacy and safety. Available in 45mg/0.5mL, 90mg/mL prefilled syringes, and 130mg/26mL vial for IV infusion, expected by Feb 2025.