Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins

We have adopted this International Scientific Guideline - EMEA/CHMP/BMWP/14327/2006.

Last updated

4 June 2024

About this guideline

Overseas effective date: April 2008

Categories: Multidisciplinary | Biosimilar | Other relevant guidelines

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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