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Biosimilar Interchangeability Requirements Pushed At Inflectra Review

 
• By Sue Sutter

Celltrion is not seeking interchangeable status, but it had data on a single transition from EU-approved Remicade; however, FDA's advisors said data on multiple switches between products would more accurately reflect real-world clinical practice.

The Arthritis Advisory Committee's discussion of interchangeability during its review of Celltrion Inc.'s Inflectra (CT-P13) highlights the information gap that FDA will have to bridge with clinicians, patients and others both before and after a biosimilar is deemed to be interchangeable with its reference product.

Celltrion is not seeking interchangeable status for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s Remicade (infliximab). Nevertheless, the...

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Infographic: Leqembi – A Geographical Comparison

 
• By Anabel Costa-Ferreira

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.

To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 
• By Sarah Karlin-Smith

FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.

Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

 
• By Kate Rawson

Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.