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.

Stelara (ustekinumab, Janssen) is an interleukin (IL)-12 and IL-23 inhibitor approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

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 ...

Fresenius Kabi, an operating company of Fresenius, and Formycon AG, a leading, independent developer of high-quality ...

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.

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.

The FDA has provisionally determined that Otulfi ® will be interchangeable with the reference drug Stelara ®, following ... 90 mg/mL single-dose prefilled syringe for injection and a 130 mg ...

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