Feel The Quality: Biosimilars Dominate Standards Setting Debate In EU
The quality issues that the European Medicines Agency considers when it evaluates biosimilar medicines became clearer during a recent event held in Strasbourg, France, where delegates also learned more about the role of European Pharmacopoeia monographs in ensuring the quality of biosimilars.
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Quality standards for biological medicines are in the spotlight again, with the UK medicines regulator, the MHRA, in the midst of consulting stakeholders on how to ensure that publicly available monographs are suitable for biologicals in the future.
A European Pharmacopoeia pilot project has resulted in the establishment of monographs for a number of complex biotherapeutics that will set “robust” standards for the development of biosimilars in the future.
Quality data will be focus of ‘extra advice’ offered by European Medicines Agency’s pilot, which will suggest directions for sponsors’ next steps but stop short of formal data evaluation.