The TGA has recently released their updated guidance on the ‘Regulation of biosimilar medicines’ v 2.0, Dec 2015. A few preliminary thoughts:

  • The section on Reference Medicines has been updated. In order to register a biosimilar in Australia the reference product must be a biological medicine which is registered in Australia on the basis of full quality, safety and efficacy data. The use of reference product, which is not registered in Australia, may however be acceptable for certain clinical and in vivo non-clinical studies on the proviso that this reference product is approved for general marketing by a well-recognised regulatory authority (i.e. EMA or FDA) and a bridging study is included which supports the comparability of the overseas reference product with that seeking approval in Australia.
  • Important to establish that the in-house primary reference standard is comparable to both the reference medicine and the biosimilar in the comparability exercise. The in-house reference will then be useful for providing a comparison with the product post-approval especially as changes occur after registration
  • The data requirements have been more explicitly stated and reference the updated EMA guidelines on the quality issues relevant to biosimilars[i]. Likewise the updated EMA non-clinical and clinical guideline are referenced [ii]

[i] The TGA has adopted EMA/CHPM/BWP247713/2012 ‘Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance; quality issues (revision 1)’ as a replacement to the 2005 version (EMEA/CHMP/BWP/49348/2005).

[ii] The TGA has adopted EMEA/CHMP/BMWP/42832/2005 Rev 1: Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues.