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Colombian decree will allow 'non-comparable' biologics, say R&D firms

This article was originally published in SRA

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Executive Summary

The publication of a Colombian decree on the evaluation of biotechnological medicines has caused something of a stir, not least because it offers three separate approval pathways, one of which R&D-based companies say will allow the approval of 'non-comparable' versions of originator biologic medicines1.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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