Guideline on similar biological medicinal products

We have adopted this International Scientific Guideline - CHMP/437/04 Rev 1

Last updated

8 January 2025

About this guideline

Overseas effective date: 30 April 2015

Replaces: CHMP/437/04 (adopted by TGA 15 June 2006)

Categories: Biologicals | Active substance | Comparability and biosimilarity

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.
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