The proof and evidence base needed to support the marketing authorization and rollout of a biosimilar medicine is based on a robust assessment of biosimilarity. Biosimilar molecules must be highly similar to the reference product and must demonstrate that there are no clinically meaningful differences in terms of quality, safety and efficacy profiles. In analytical assessments similar structure, physicochemical attributes and biological binding activity must be demonstrated. Followed by comparability studies, to show equivalent pharmacokinetics and efficacy, as well as similar safety profile and immunogenicity. Therefore, biosimilars can be considered as therapeutic alternatives to reference products. Manufacturers of biologic therapies as well as regulatory agencies are constantly reviewing evidence to make sure there are no major differences in efficacy and safety of biosimilars compared to biologic drugs to ensure consistent and appropriate consumption for human use.1,2,3
