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

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.

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 ...

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 ...

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 ...

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.

"In addition to approving Otulfi last year for all indications matching the reference product Stelara, the FDA has ... and 90 mg/mL single-dose prefilled syringe for injection and a 130 mg/26 ...

STEQEYMA®, one of the first-wave biosimilars to STELARA®, is now available in the U.S. Approved for the same indications as ...