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We wish to respond to commentary about our paper [1], “A ‘Global Reference’ Comparator for Biosimilar Development,” made in the article by Tu et al. [2] recently published in BioDrugs. In our paper, we set out a case for bridging studies between versions of a biosimilar reference product approved in different jurisdictions (most notably, the EU and the USA) to be not required when a sponsor can substantiate from information already in the public domain that both versions were approved based on at least some of the same phase III clinical studies. We proposed an evidentiary basis for the acceptance of a foreign version of a reference product as a comparator in permitted studies to establish biosimilarity that is much simpler and less costly than that expected currently in these jurisdictions. Further, we showed that this principle can be generalized to permit any version of the reference product approved in a “highly regulated” jurisdiction to serve as a comparator in permitted studies in all other jurisdictions—hence, the concept of the “global comparator”. We commend Tu et al. [2] for their paper, which confronts the same problem and supports by careful data analysis our contention that costly and duplicative studies are unnecessary to qualify a comparator for permitted studies when the terms of our proposed evidentiary basis are satisfied. However, in their comments on our paper, the authors stated,

biodrugs

Comment on “Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU-Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?”