Transcription of Guideline on similar biological medicinal products ...
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Guideline on similar biological medicinal products ...
30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged. 18 December 2014 EMEA/CHMP/BMWP/42832/2005 Rev1 Committee for medicinal products for Human Use (CHMP) Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues Draft agreed by Biosimilar medicinal products Working Party (BMWP) April 2013 Adopted by CHMP for release for consultation 30 May 2013 Start of public consultation 03 June 2013 End of consultation (deadline for comments) 30 November 2013 Agreed by Biosimilar medicinal Pro
addresses the requirements for pharmacokinetic, pharmacodynamic, and efficacy studies. The section on clinical safety and pharmacovigilance addresses clinical safety studies, including immunogenicity, as ... Factors to be considered when the need for in vivo non-clinical studies is evaluated, include, but are
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