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?”

• Published in: BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy biopharmaceuticals, and gene therapy, 2019-10, Vol.33 (5), p.581-582
• Main Authors: Webster, Christopher J., Woollett, Gillian R.
• Format: Article
• Language: English
• Subjects: Antibodies; Biological products; Biomedical and Life Sciences; Biomedicine; Cancer Research; Conflicts of interest; FDA approval; Jurisdiction; Letter to the Editor; Licenses; Manufacturing; Molecular Medicine; Pharmacodynamics; Pharmacokinetics; Pharmacotherapy
• ISSN: 1173-8804; 1179-190X
• DOI: 10.1007/s40259-019-00372-3

[...]in their comments on our paper, the authors stated, "Post-approval manufacturing changes or production site transfers were tightly controlled by regulatory authorities and the consistency between pre- and post-changed products were evaluated using the same principles and guidelines (e.g., International Conference on Harmonisation Q5E) adopted by most countries worldwide. According to the arguments of Webster and Woollett, there was no reason to believe there would be any distinct variations among different sources of reference biological products. To summarize, in our view, the reason why elaborate studies are unnecessary, and actually superfluous, when it is known that the two versions of the reference have been approved on the same clinical data is not because quality differences may not exist but because they will make no difference in the studies for which a foreign comparator is permitted in the EU and USA. Since it is clearly necessary to document an objective relationship between the reference product versions in order to qualify the foreign version as a proxy for the local version, the substantiated fact that both versions were approved on the same clinical data serves that purpose.