Ustekinumab
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.
Stelara, Entyvio have ‘comparable’ cardiovascular safety profiles in older adults with IBD
SAN FRANCISCO — Although Stelara and Entyvio demonstrated similar cardiovascular safety profiles among older patients with inflammatory bowel disease, Stelara was associated with reduced all-cause mortality risk over 3 years, data showed.
FDA approves Yesintek, sixth Stelara biosimilar; launch slated for February
The FDA has approved the Stelara biosimilar Yesintek for indications matching the reference product, with a commercial launch date expected for early 2025, according to a press release from Biocon Biologics.
Imuldosa snags FDA approval as fifth Stelara biosimilar in mounting market logjam
The FDA has approved the Stelara biosimilar, Imuldosa, for Crohn’s disease, ulcerative colitis and all other indications of the reference product, and the latest addition to the Stelara biosimilar bottleneck set to release in 2025.
FDA approves Otulfi as fourth Stelara biosimilar for chronic inflammatory diseases
The FDA has approved subcutaneous and IV formulations of the Stelara biosimilar Otulfi for Crohn’s disease, ulcerative colitis and all other indications approved for the reference product, according to a press release from Fresenius Kabi.
First-line treatment with vedolizumab linked to fewer hospitalizations, surgeries in IBD
The treatment sequence of vedolizumab to adalimumab resulted in the lowest overall incidences of hospitalization and surgery in both Crohn’s disease and ulcerative colitis compared with other biologic treatment sequences, research showed.
Enbrel, Stelara to be discounted nearly 70% through Medicare price negotiations
The list prices of Stelara and Enbrel for Medicare users will be discounted nearly 70% come 2026 as a result of the first round CMS price negotiations with drugmakers, the White House has announced.
Medicare announces price cuts for 10 drugs in first round of drug price negotiations
The Centers for Medicare & Medicaid Services announced lower Medicare Part D prices for 10 drugs that will take effect in 2026, according to a press release.
Skyrizi outperforms Stelara in endoscopic remission at week 48 in Crohn’s disease
Although Skyrizi was noninferior to Stelara in clinical remission at week 24, it was superior in endoscopic remission at week 48 in patients with moderate to severe Crohn’s disease, according to data from the SEQUENCE trial.
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.