Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use

We have adopted this International Scientific Guideline - EMA/CHMP/BMWP/86289/2010.

Last updated

4 June 2024

About this guideline

Overseas effective date: 1 December 2012

Replaces: Concept paper EMEA/CHMP/BMWP/114720/2009 on this topic (provided for information 15 July 2009)

Categories: Multidisciplinary | Biosimilar | Other guidelines relevant for biosimilars

TGA annotations: Nil

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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