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

Guidance on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor

We have adopted this International Scientific Guideline - EMEA/CHMP/BMWP/31329/2005.

Last updated

3 June 2024

About this guideline

Overseas effective date: 1 June 2006

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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