In Manufacturing, Absence Of Evidence Is Not Evidence Of Absence, FDA Tells BioMarin

BioMarin showed that the Vimizim BLA did not have enough data to prove that clinical and commercial sites are different. That’s not the same as concluding there is no difference between the sites, FDA said.

FDA would not accept the lack of a statistically significant difference between the Vimizim biologic produced at the clinical and commercial manufacturing sites as evidence of their comparability, review documents show.

Manufacturing scale-up is a common source of review issues for biologics. BLA sponsors are required to show that products produced...

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