Crohn’S Diseases
First four Stelara biosimilars launch in US; ‘white labeling’ threatens market ‘vibrancy’
Four biosimilars for Stelara have launched in the United States this year following legal settlements with the reference product manufacturer, Janssen Pharmaceuticals, which set timelines for their market entries.
Disease Management Based on Clinical Severity
Intestinal ultrasound may predict Stelara response at 1 year in Crohn’s disease
Multimodal intestinal ultrasound performed at 24 weeks can provide “useful information” for predicting endoscopic response at 1 year in patients with active Crohn’s disease initiating treatment with Stelara, according to researchers.
Socioeconomic Impact and Prognosis
Coherus to launch adalimumab biosimilar in US at 85% discount
Coherus BioSciences’ adalimumab biosimilar, Yusimry, will make its debut in the U.S. marketplace this summer at an 85% discount compared with the originator Humira, according to the manufacturer.
FDA approves ‘high-concentration, citrate-free’ Yuflyma as ninth Humira biosimilar
The FDA has approved Celltrion USA’s Yuflyma as the ninth biosimilar to adalimumab for all eligible indications of the reference product, and the latest in a flood of biosimilars cleared for 2023 release in the United States.
FDA approves autoinjector option for upcoming adalimumab biosimilar
The FDA has given the green light to a new autoinjector option for the interchangeable adalimumab biosimilar Cyltezo, just weeks ahead of its scheduled debut in the United States, according to a press release from the manufacturer.
Top in GI: Dual biologic therapy in IBD; hyperbaric oxygen therapy in fistulizing Crohn’s
Last week, Healio provided coverage of the Crohn’s and Colitis Congress.
Celltrion submits application for subcutaneous infliximab in inflammatory bowel disease
Celltrion has submitted a biologics license application to the FDA for the consideration of a subcutaneous formulation of infliximab in the treatment of inflammatory bowel disease, according to a press release.
Skyrizi induction, maintenance therapy improves patient-reported symptoms in CD
CHARLOTTE, N.C. — Patient-reported outcomes of abdominal pain and stool frequency improved with risankizumab induction, while maintenance therapy was effective for symptomatic remission and resolution in patients with Crohn’s disease.