Fresenius Kabi Launches Otulfi (Biosimilar, Stelara) in the US
Shots:
- Fresenius Kabi has launched Otulfi (ustekinumab- aauz) injection, a biosimilar to Stelara, developed by Formycon AG to treat mod. to sev. Crohn’s disease, ulcerative colitis, and plaque psoriasis & active psoriatic arthritis (age ≥ 6 yrs.) across the US
- Otulfi will be available in the US in 45 mg/0.5 mL and 90 mg/mL prefilled syringes for injection, and a 130 mg/26 mL vial for IV. A 45 mg/0.5 mL single-dose vial for SC is expected to receive FDA approval in H1’25
- In February 2023, Fresenius Kabi and Formycon formed a global partnership to commercialize ustekinumab biosimilar, which received FDA approval in September 2024
Ref: Businesswire | Image: Fresenius Kabi
Related News:- Fresenius Kabi Reports the US FDA’s 510(k) Clearance for Adaptive Nomogram, Improving Plasma Collection Efficiency
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