Gillian Woollett, MA, DPhil: Creating a Paradigm Shift in Biosimilar Development

1. You recently proposed that the “tshould be revised in favor of a “confirmation of sufficient likeness” paradigm. Can you briefly describe what you mean by sufficient likeness in this context?

Transcript

In biologics the whole question and for biosimilars has been whether they can be defined analytically. We now have the methods to define them sufficiently well that the question becomes, what else do you need? So our confirmation of sufficient lightness is based on the analytics, establishing that indeed, the two products you're comparing—the reference and the biosimilar candidate—are sufficiently alike, and we chose the new terminology so as not to imply a difference. And once you've got the confirmation, sufficient lightness analytically, then what our paper shows—and that'll be referenced—what our paper shows is that the biosimilars worldwide in US, Europe, Australia and Canada, if the PK [pharmacokinetic] matches, that product was going to be approved as biosimilar. So that then becomes the confirmation of sufficient likeness. And what we're asserting in the paper is there's no need for additional clinical studies, because they won't tell you anything. And if a clinical study won't tell you anything, it lacks scientific validity. Therefore, it lacks ethical validity. And it shouldn't be being done, and certainly not routinely.

We also would like to note that our paper, which was published in August [2019] in BioDrugs, subsequently, the European regulators have published a paper, also in BioDrugs in September, and they're coming to the same conclusions just based on European data. So we think there's definitely a case to be made here to revisit what you're doing, and therefore a new paradigm is entirely appropriate and we just like confirmation

of sufficient lightness.

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