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International scientific guidelines: Guideline on similar biological medicinal products

CHMP/437/04 Rev. 1 adopted by the Therapeutic Goods Administration (TGA)

About this guideline

Overseas effective date: 25 May 2015

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

Categories: Biological medicines | Drug substance | Comparability/biosimilarity | Multidisciplinary | Biosimilars | Overarching

Access this international scientific guideline

For more information see International scientific guidelines adopted in Australia.

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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