As biosimilar medicines are designed and engineered using the latest technology to resemble their reference product as closely as possible, demonstrating high similarity is at the foundation of biosimilar medicine development.1 All critical quality attributes (i.e. those impacting the function of the molecule) have been carefully evaluated to demonstrate no clinically meaningful differences.2
The complex nature of biological medicines means a more rigorous comparability exercise of a biosimilar medicine to its reference biological is warranted than for generics of small-molecule drugs.1-6
Biosimilar medicines are approved on the totality of evidence gathered through a stepwise approach of comprehensive preclinical assessments and a tailored clinical program to confirm there are no differences in clinical efficacy, safety or immunogenicity between the biosimilar medicine and its reference biological.1-5,7
- Weise M, Bielsky MC, De Smet K et al. Blood. 2012;120(26):5111-5117.
- Australian Government – Department of Health. Biosimilar medicines: the basics for health care professionals. P11756. Updated: March 2017. Available here. 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.
- 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.
- Lee JF, Litten JB, Grampp G. Curr Med Res Opin 2012;28(6):1053-1058.
- 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