Biosimilar Switching Studies, Human Factors Analyses Are Flashpoints For Industry

US FDA should offer more flexibility on endpoint in clinical switching studies for interchangeability, generic companies say in comments that also argue a draft guidance recommendation for human factors studies to compare use error rates between products is misplaced.

The US FDA’s recommendations for clinical switching study designs and human factors study testing of proposed interchangeable biosimilar products elicited strong, and sometimes divergent, views from the biopharma industry.

In comments on FDA’s January draft guidance, “Considerations in Demonstrating Interchangeability With a Reference Product,” industry groups and companies generally...

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