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

Guideline on similar medicinal products containing somatropin

We have adopted this International Scientific Guideline - EMEA/CHMP/BMWP/94528/2005 Rev. 1.

Last updated

About this guideline

Adopted by the TGA: 8 June 2023

Overseas effective date: 1 January 2019

Replaces: EMEA/CHMP/BMWP/94528/2005

Note: this is a technical update to reflect current best practise with regard to implementation of 3Rs approaches and it is not intended as a full revision of guideline (only section 4 is affected) EMEA/CHMP/BMWP/94528/2005

Categories: Multidisciplinary | Biosimilars | Product-specific

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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For more information see International scientific guidelines adopted in Australia.

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