While interchangeability is a legislative issue in the United States as described in the Biologics Price Competition and Innovation Act (BPCIA), where an approved biosimilar product is further tested using switching and interchanging to qualify the interchangeable status. This should not have been unexpected based on Plato's principle of equality that if A=B and C=A, then B=C. Another publication recently concluded that interchanging from one biosimilar to another biosimilar is safe and effective. The concurrence by EMA is a game-changer as it will bring high confidence among the stakeholders who may be unsure about the safety and efficacy of biosimilars. The focus of this publication was to convince the US Congress and the US FDA to remove the interchangeable status, as it adds to uncertainty about biosimilars. I had the privilege of submitting a detailed analysis of why biosimilars should be interchangeable without requiring additional studies, switching, and alternating, as needed in the United States. While the US maintains a special interchangeable status for biosimilars, the European Medicines Agency (EMA) had left the decisions to the member states until this week, as it released its new guidance that makes biosimilars interchangeable with their reference products.
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