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Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)

We have adopted this International Scientific Guideline - EMA/CHMP/BWP/247713/2012 

Last updated

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.
  • 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.

For more information see International scientific guidelines adopted in Australia.

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