NOR-SWITCH Results ‘Concerning’ In Crohn’s Disease, Says Janssen

Janssen Biotech says that the NOR-SWITCH study on switching from Remicade to biosimilar infliximab raises “significant questions” over safety and efficacy in patients with Crohn’s disease, and does not support interchangeability.

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How far should biosimilars be interchangeable?

The results of NOR-SWITCH, the Norwegian government-sponsored study on switching patients from Johnson & Johnson’s Remicade (infliximab) to Celltrion’s biosimilar version Remsima (CT-P13), have generated a great deal of controversy since they were published last month, especially over how far the data support the safety of switching.

More from Biosimilars

More from Biosimilars & Generics

US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 

The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Biosimilars Industry Celebrates EMA’s Plan to Reduce Clinical Trials

 
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The European Medicines Agency’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam.