Biosimilar medicines are required to undergo a tailored clinical program. This is normally a stepwise process, beginning with pharmacokinetic/pharmacodynamic (PK/PD) studies followed by head-to-head clinical efficacy and safety trial(s).1-4
The TGA has adopted EMA guidelines for the non-clinical and clinical regulation of biosimilar medicines as well as developed Australia-specific guidance, which provide disease- and product-class-specific guidance on biosimilar clinical programs.2,4,5
For example, biosimilar insulins may not require a pre-licensing safety and immunogenicity study if non-clinical physiochemical, functional and pharmacodynamic profiles are convincingly similar.6 Conversely, biosimilar medicines of more complex monoclonal antibody therapeutics should always require an adequately powered, randomised, parallel-group comparative Phase III clinical trial(s).7
The aim of the clinical program is to confirm therapeutic equivalence between the biosimilar medicine and its reference biological medicine, as opposed to clinical superiority or non-inferiority.1,2
The regulatory conditions for biosimilar medicines in Australia
mean that a biosimilar medicine approved for use in the Australian market can
be said to have no clinically meaningful
differences and be therapeutically equivalent to its reference product.
Once approved, healthcare professionals and patients can expect similar health
outcomes whether the biosimilar medicine or its reference biological is used.1,5
- Australian Government – Department of Health. Biosimilar medicines: the basics for health care professionals. P11756. Updated: March 2017. Available at: http://www.health.gov.au/internet/main/publishing.nsf/content/ biosimilar-awareness-initiative/$File/Biosimilar-medicines-the-basics-for-healthcare-professionals-Brochure.pdf Accessed 27 August 2018.
- Dörner T, Strand V, Castañeda-Hernández G et al. Ann Rheum Dis 2013;72(3):322-328.
- Schneider CK. Ann Rheum Dis 2013;72(3):315-318.
- European Medicines Agency. EMEA/CHMP/BMWP/42832/2005 Rev 1: Guideline on similar biological medicinal products Containing Biotechnology-Derived Proteins as Active Substances: Non-Clinical and Clinical Issues. Effective 1 July 2015.
- Therapeutic Goods Administration. Biosimilar medicines regulation, Version 2.2. Accessed from: https://www.tga.gov .au/publication/biosimilar-medicines-regulation. Updated: April 2018. Accessed on: 27 August 2018.
- European Medicines Agency. EMEA/CHMP/BMWP/32775/2005_Rev. 1: Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues. Effective 1 September 2015.
- European Medicines Agency. EMEA/CHMP/BMWP/118264/2007 Rev 1: Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies: Non-Clinical and Clinical Issues. Effective 30 May 2012.