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ema biosimilar guidelines
guideline on similar biological medicinal products containing biotechnology-derived proteins

EMA Logo Published, 29/10/2014. Effective from, 30/04/2015. Keywords, Similar biological medicinal product, biosimilar, biosimilarity exercise, comparability exercise, reference Adopted guideline, In operation: 30/10/2005–29/04/2015 9 Jun 2014 On 22 May 2014, the European Medicines Agency ("EMA") published a of its Guideline on similar biological medicinal products containing bi. 18 December 2014. EMEA/CHMP/BMWP/42832/2005 Rev1. Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological 30 May 2012 Non-clinical and Clinical Issues. EMA/CHMP/BMWP/403543/2010. Page 2/16. Guideline on Similar Biological Medicinal Products. Containing E-mail: mail@emea.eu.int www.emea.eu.int. ©EMEA . [for similar biological medicinal products] are addressed in a guideline taking into account the. 22 May 2014. EMA/CHMP/BWP/247713/2012. Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products. 30 Aug 2017 The European Medicines Agency (EMA) has taken the lead over the past 10 years in shaping .. Guideline on similar biological medicinal products containing 18 December 2014. www.ema.europa.eu/docs/en_GB/ 23 Oct 2014 Send a question via our website www.ema.europa.eu/contact July 2014 similar biological medicinal product, biosimilar, biosimilarity European medicines agency guideline for biological medicinal products: a further revision of the guideline on similar biological medicinal products containing European Medicines Agency (EMA) has published on December 18, 2014 [1].4 Jul 2014 On 26 June 2014, the European Medicines Agency (EMA) published the new Guideline on similar biological medicinal products containing