Biosimilar Interchangeability Requirements Pushed At Inflectra Review

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 Feb. 9 advisory committee meeting featured a host of questions...

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