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Ustekinumab

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March 04, 2025
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First four Stelara biosimilars launch in US; ‘white labeling’ threatens market ‘vibrancy’

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.

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February 13, 2025
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Stelara, Entyvio have ‘comparable’ cardiovascular safety profiles in older adults with IBD

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.

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December 02, 2024
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FDA approves Yesintek, sixth Stelara biosimilar; launch slated for February

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.

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October 14, 2024
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Imuldosa snags FDA approval as fifth Stelara biosimilar in mounting market logjam

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.

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September 30, 2024
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FDA approves Otulfi as fourth Stelara biosimilar for chronic inflammatory diseases

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.

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September 25, 2024
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First-line treatment with vedolizumab linked to fewer hospitalizations, surgeries in IBD

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.

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August 15, 2024
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Enbrel, Stelara to be discounted nearly 70% through Medicare price negotiations

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.

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August 15, 2024
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Medicare announces price cuts for 10 drugs in first round of drug price negotiations

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.

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August 12, 2024
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Skyrizi outperforms Stelara in endoscopic remission at week 48 in Crohn’s disease

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.

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July 23, 2024
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Intestinal ultrasound may predict Stelara response at 1 year in Crohn’s disease

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.

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