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The EMA Publishes New Biosimilars Guideline on Non-Clinical and Clinical Issues

15 January 2015

Focus on Regulation - Hogan Lovells Blog

Following its adoption by the Committee for Medicinal Products for Human Use (“CHMP”) on 18 December 2014, the European Medicines Agency (“EMA”) recently published a finalised version of its Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (hereafter “EMA Guideline”). The revised EMA Guideline is expected to come into force in July 2015 and will replace the current guideline which came into effect in June 2006.

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