Biosimilars entering the clinic without animal studies
نویسندگان
چکیده
Leon AGJM van Aerts*, Karen De Smet, Gabriele Reichmann, Jan Willem van der Laan, and Christian K Schneider Medicines Evaluation Board (CBG-MEB); Utrecht, Netherlands; Member of the Safety Working Party (SWP); EMA; London, UK; Expert of the Working Party on Similar Biological Medicinal Products (BMWP) of the Committee for Medicinal Products for Human Use (CHMP); EMA; London, UK; Federal Agency for Medicines and Health Products (FAMHP); Brussels, Belgium; Expert of the SWP of the CHMP; EMA; London, UK; Member of the BMWP; EMA; London, UK; Paul Ehrlich Institute (PEI); Langen, Germany; Chair of the SWP; EMA; London, UK; Danish Health and Medicines Authority (DHMA); Copenhagen, Denmark, and Twincore Centre for Experimental and Clinical Infection Research; Hanover, Germany; Chair of the BMWP; EMA; London, UK
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