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Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins

We have adopted this International Scientific Guideline - EMEA/CHMP/BMWP/301636/2008 Rev. 1.

Last updated

About this guideline

Adopted by the TGA: 08 June 2023

Overseas effective date: 1 January 2019

Replaces: EMEA/CHMP/BMWP/301636/2008 Corr.*

Note: This is a technical update to reflect current best practise with regard to implementation of 3Rs approaches and is not intended as a full revision of guideline (only Section 4 is affected) EMEA/CHMP/BMWP/301636/2008 Corr.*

Categories: Multidisciplinary | Biosimilar | Product-specific

TGA annotations:

Demonstration of efficacy in renal anaemia will support extrapolation to other indications of the reference medicinal product with the same route of administration. It is recommended that potential safety issues in different populations be addressed by conducting clinical studies in the different populations (e.g. renal anaemia and cancer patients).

  • 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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