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Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues

We have adopted this International Scientific Guideline - EMEA/CHMP/BMWP/32775/2005 Rev. 1.

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About this guideline

Overseas effective date: 1 September 2015

Replaces: EMEA/CHMP/BMWP/32775/2005 Annex to Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues. Guidance on Similar Medicinal Products Containing Recombinant Human Insulin (Adopted by TGA 12 September 2006)

Categories: Multidisciplinary | Biosimilar | Product-specific biosimilar guidelines

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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