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About this guideline
Overseas effective date: 1 December 2014
Replaces: EMEA/CHMP/BWP/49348/2005. Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Quality Issues (adopted by TGA December 2006)
Categories: Biologicals | Active substance | Comparability and biosimilarity, and Multidisciplinary | Biosimilar | Overarching biosimilar guidelines
TGA annotations:
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.
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For more information see International scientific guidelines adopted in Australia.