Celltrion and Formycon with Fresenius Kabi launched their respective ustekinumab biosimilars (Steqeyma and Otulfi), joining 4 ...

It encompasses all indications approved for the STELARA® reference product ... 45mg/0.5 mL or 90mg/1 mL solution in a single-dose, prefilled syringe. The intravenous infusion is provided ...

Otulfi ® is an ustekinumab biosimilar for the reference product Stelara ® (ustekinumab ... a 45 mg/0.5 mL and 90 mg/mL single ...

The FDA had approved Otulfi in September 2024 to treat Crohn’s disease, ulcerative colitis, psoriasis and active psoriatic arthritis. Information on pricing is not yet available.

FYB202/Otulfi ® (ustekinumab-aauz), a biosimilar to Stelara®, launched in the United States and the European Union FYB202/Otulfi ® is now commercially available in both subcutaneous and intravenous ...

Selarsdi (ustekinumab-aekn; Teva and Alvotech), and Yesintek (ustekinumab-kfce; Biocon Biologics), all biosimilars to Stelara (ustekinumab; Johnson & Johnson) are now available in the US.

The FDA has provisionally determined that SELARSDI will be interchangeable with the reference biologic Stelara®, following ... mL in a single-dose prefilled syringe for subcutaneous injection ...

It encompasses all indications approved for the STELARA® reference product ... 45mg/0.5 mL or 90mg/1 mL solution in a single-dose, prefilled syringe. The intravenous infusion is provided as a ...

Celltrion today announced the U.S. launch of STEQEYMA��(ustekinumab-stba), a biosimilar to STELARA� (ustekinumab), following approval by the U.S. Food and Drug Administration (FDA) in December 2024.