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Venezuela extends comment period for draft biosimilars guidance

This article was originally published in Scrip

Executive Summary

Companies wishing to comment on the draft Venezuelan biosimilars guidance now have more time to do so, after the authorities extended the consultation period from mid-December to 28 February 2014. As well as explaining the preclinical and clinical requirements of the comparability exercise, the guidance allows for the extrapolation of indications provided certain criteria are met.

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