Considerations in Demonstrating Interchangeability With a Reference Product

PDA is a non-profit international professional association of more than 10,000 individual member scientists having an interest in the fields of pharmaceutical, biological, and device manufacturing and quality. This response addresses aspects of the draft related to delivery, design, and human factors considerations and was prepared by the members of the Combination Products Interest Group on behalf of the Regulatory and Quality Advisory Board and Board of Directors. It is PDA's recommendation that the goals for any Human Factors studies performed on a biosimilar claiming interchangeability are essentially the same as for those already in international standards, published literature and established FDA guidance documents. It is important to note that the latest revision of the IEC 62366-1 standard specifically eliminated the setting of usability goals and acceptance of statistical measures as evidence of success and now provides the more widely accepted assessment of the overall risk of critical task use errors through investigation, root cause determination and mitigation, or justification/acceptance of the risk.