Transcription of Guideline on Immunogenicity assessment of therapeutic …
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Guideline on Immunogenicity assessment of therapeutic …
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, 2017. Reproduction is authorised provided the source is acknowledged. 18 May 2017 EMEA/CHMP/BMWP/14327/2006 Rev 1 Committee for Medicinal Products for Human Use (CHMP) Guideline on Immunogenicity assessment of therapeutic proteins Draft revision agreed by Biosimilar Medicinal Products Working Party (BMWP) August 2015 Adopted by CHMP for release for consultation 24 September 2015 Start of public consultation 01 October 2015 End of consultation (deadline for comments) 31 January 2016 Agreed by Biosimilar Medicinal Pro
Methodological aspects to assess relative immunogenicity as part of a comparability ... immunomodulating therapy . Treatment-related factors include dosing schedule and route of ... advanced malignant disease, advanced HIV disease, organ failure), an immune response might be less likely to occur due to an impaired immune system.
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