Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues

We have adopted this International Scientific Guideline - EMEA/CHMP/BMWP/42832/2005 Rev1

Last updated

15 July 2024

About this guideline

Overseas effective date: 1 July 2015

Replaces: EMEA/CHMP/BMWP/42832/2005 (adopted by TGA September 2006)

Categories: Multidisciplinary | Biosimilar | Overarching biosimilar 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.
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.

Product types