Guideline on similar biological medicinal products containing monoclonal antibodies - non-clinical and clinical issues

We have adopted this International Scientific Guideline - EMA/CHMP/BMWP/403543/2010

Last updated

15 July 2024

About this guideline

Overseas effective date: 1 December 2012

Replaces: concept paper EMEA/CHMP/BMWP/632613/2009 (provided for information 26 March 2010)

Categories: Multidisciplinary | Biosimilar | Product-specific biosimilar guidelines

Sponsors should also refer to TGA guidance on the Evaluation of biosimilars

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.
All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

Topics