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The importance of monoclonal antibodies as a product class and the challenge of assessing unwanted immunogenicity for these products have prompted the drafting of a new CHMP (Committee for Medicinal Products for Human Use) guideline. The ‘Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use’ is intended as an annex to the existing general immunogenicity guideline. This guidance in conjunction with other relevant CHMP guidelines should assist manufacturers and regulators who are involved with producing or assessing marketing authorization applications for monoclonal antibody products

New CHMP Guideline on immunogenicity of monoclonal antibodies