Sandoz has been making the case in recent public presentations, publications and regulatory guidance comments that companies developing biosimilars may end up knowing more about structure/function and product/process relationships than the companies originating the products they are targeting.
The presumption of a knowledge gap between originators and biosimilar developers about these relationships is reflected in the need being voiced for clinical studies on biosimilars to support the analytical comparability work and for additional requirements for interchangeability.
Sandoz is stepping up to the plate to take issue with this presumption – at least for firms like itself with a wealth of knowledge and experience to draw on in both the innovator and biosimilar arenas.
Commenting on the time- and resource-intensive nature of the biosimilar development process at the PDA annual meeting in Phoenix in April, Sandoz Global Head of Pharmaceutical Development Mark McCamish maintained that “as a biosimilar manufacturer, we often know more about the structure/function relationships than the originator.”
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