Healio7d
Tremfya’s FDA win as fully subcutaneous option for Crohn’s may pave way to eclipse Stelara
The FDA has approved Tremfya as the “first and only” interleukin-23 inhibitor that offers both IV and fully subcutaneous ...
Hosted on MSN3mon
Alpha-Gal May Drive Sensitivity to IV Stelara in People With Red-Meat Allergies
ORLANDO -- First-dose reactions to IV ustekinumab (Stelara) may be related to IgE recognition of a carbohydrate allergen in patients, who may be able to tolerate subcutaneous ustekinumab instead ...
Fierce Pharma8d
J&J advances Stelara succession scheme with FDA nod for Tremfya in Crohn's disease
With another inflammatory bowel disease (IBD) approval in the bag for Tremfya, Johnson & Johnson continues to make good on ...
TREMFYA® (guselkumab) receives positive CHMP opinion for treatment of patients with moderately to severely active Crohn’s Disease
Recommendation based on the findings from the Phase 3 studies (GALAXI programme and GRAVITI) in Crohn’s disease 1,2,3 Beerse, Belgium (28 March 2025) – Johnson & Johnson today announced that the ...
Medscape3d
FDA OKs Guselkumab for Crohn’s Disease
Guselkumab is the first and only interleukin-23 inhibitor that offers both subcutaneous and intravenous induction options for ...
Hosted on MSN7d
FDA approves Johnson & Johnson’s Tremfya to treat Crohn’s disease
GALAXI clinical programme data revealed that the antibody was superior to Stelara across all pooled endoscopic endpoints. The ...
Business Wire25d
Fresenius Continues Growth of Biosimilars Portfolio with the U.S. Availability of Otulfi ® (ustekinumab-aauz)
Otulfi ® is an ustekinumab biosimilar for the reference ... single dose vial for IV infusion. Otulfi in a 45 mg/0.5 mL single-dose vial for subcutaneous injection is expected to receive FDA ...
Business Insider1mon
Teva and Alvotech Announce SELARSDI™ (ustekinumab-aekn) Injection Now Available in the U.S.
The FDA has provisionally determined that SELARSDI will be interchangeable with the reference biologic Stelara ®, following the expiration of exclusivity for the first interchangeable biosimilar ...
Healio24d
First four Stelara biosimilars launch in US; ‘white labeling’ threatens market ‘vibrancy’
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.
The Victoria Advocate17d
STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), now available in the United States
STEQEYMA ®, one of the first-wave biosimilars to STELARA ®, is now available in the U.S. Approved for the same indications as the reference product, STEQEYMA will be priced with a wholesale ...
Yahoo Finance25d
Fresenius Continues Growth of Biosimilars Portfolio with the U.S. Availability of Otulfi® (ustekinumab-aauz)
(Photo: Business Wire) The Fresenius ustekinumab biosimilar ... single dose vial for IV infusion. Otulfi in a 45 mg/0.5 mL single-dose vial for subcutaneous injection is expected to receive ...
Stockhouse17d
STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), now available in the United States
JERSEY CITY, N.J., March 12, 2025 /PRNewswire/ -- Celltrion today announced the U.S. launch of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), following ...