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Biosimilar MAbs in EU will need extensive clinical trials and post-approval monitoring

This article was originally published in SRA

Executive Summary

A long awaited draft guideline from the European Medicines Agency confirms that companies wanting to develop and register biosimilar monoclonal antibodies in the EU will have to have conduct extensive clinical trials, pay close attention to possible immunogenicity problems, and put in place a substantial post-authorisation safety monitoring programme1.

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