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EMA will accept biosimilar reference products sourced outside EEA, but not immediately

This article was originally published in SRA

Executive Summary

The European Medicines Agency has issued an update to its procedural advice document EMA/940451/2011 that confirms that the agency, with regard to biosimilar applications under the centralised procedure, will accept batches of reference medicinal products sourced from outside the European Economic Area in certain pre-clinical and clinical studies for the comparability exercise1. The change will not happen immediately, however.

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