Johnson & Johnson

Johnson & Johnson submitted two sBLAs to the FDA for TREMFYA (guselkumab) to treat moderate-to-severe plaque psoriasis in children aged 6 and above, and active juvenile psoriatic arthritis in those aged 5 and older.

Biocon Biologics announces FDA approval of Yesintek (ustekinumab-kfce), a sixth Stelara biosimilar, for treating inflammatory bowel disease, plaque psoriasis, and psoriatic arthritis. Yesintek, a monoclonal antibody, will be available in the U.S. by Feb. 22, 2025, under a licensing agreement with Janssen and Johnson & Johnson. Stelara, originally approved in 2009, has a list price of $13,836 per month and generated $10.86 billion in global revenue in 2023. Other Stelara biosimilars include Imuldosa, Otulfi, Pyzchiva, Selarsdi, and Wezlana. Stelara will be discounted under the Inflation Reduction Act, with Medicare members paying $4,695 for a 30-day supply starting in 2026.

Johnson & Johnson submitted 2 supplemental Biologics License Applications to the FDA for guselkumab (Tremfya) treatment of children aged 6+ with moderate-to-severe psoriasis and those aged 5+ with active juvenile psoriatic arthritis (jPsA), highlighting a commitment to transform care for patients of all ages.

Johnson & Johnson submitted sBLAs to FDA for Tremfya (guselkumab) to treat children with moderate-to-severe plaque psoriasis and active juvenile psoriatic arthritis. Tremfya, a monoclonal antibody targeting IL-23, showed efficacy in previous adult studies and ongoing pediatric trials with minimal serious adverse effects. The drug is also approved for adults with psoriatic arthritis and moderate-to-severe plaque psoriasis.

Johnson & Johnson submits two sBLAs to FDA for TREMFYA approval in children with moderate-to-severe plaque psoriasis (PsO) and active juvenile psoriatic arthritis (jPsA), based on Phase 3 PROTOSTAR study data and PK analyses.

FDA approves Yesintek (ustekinumab-kfce), the sixth biosimilar to Stelara, for treating IBD, plaque psoriasis, and psoriatic arthritis. Developed by Biocon Biologics, Yesintek is set to launch in 2025, alongside other Stelara biosimilars. Clinical trials showed Yesintek's efficacy and safety were equivalent to Stelara.

Biocon Biologics Ltd announced FDA approval of YESINTEK™ (Ustekinumab-kfce), a biosimilar to Stelara®, for treating Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. Previously, Biocon had secured a licensing agreement with Janssen to commercialize YESINTEK™ in the U.S. by February 22, 2025.

Johnson & Johnson submits two sBLAs to FDA for TREMFYA® (guselkumab) to treat children with moderate-to-severe plaque psoriasis and active juvenile psoriatic arthritis, based on Phase 3 PROTOSTAR study data and PK extrapolation analyses.