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

Otulfi ® is an ustekinumab biosimilar for the reference product Stelara ® (ustekinumab ... dose prefilled syringe for ...

It encompasses all indications approved for the STELARA® reference product ... solution in a single-dose vial. Plaque Psoriasis (PsO) in adults and pediatric patients 6 years of age and older ...

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 ...

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.

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.

Biocon Biologics, one of India's leading biologic drug manufacturers, announced on Friday the results of a Phase-3 study on a ...

YESINTEK will be available in all the same formulations currently provided by Stelara. The available presentations are 45 mg/0.5 mL PFS, 90 mg/mL PFS, 45 mg/0.5 mL vial, and 130 mg/26 mL vial.

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.

It encompasses all indications approved for the STELARA® reference product ... The intravenous infusion is provided as a 130mg/26 mL (5mg/mL) solution in a single-dose vial. Plaque Psoriasis ...