A biosimilar is a medicinal product that is similar to a biological medicinal product that has already been authorised (the ’biological reference medicinal product’).
It is a version of an already licensed drug for which similarity has been proven in an extensive comparability exercise, encompassing physical, chemical, biological and pharmacological properties, including efficacy and safety.
This excludes products in other regions of the world that have not been endorsed via the WHO pathway as a biosimilar.
A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product.
A biosimilar demonstrates similarity to the reference medicinal product in terms of quality characteristics, biological activity, safety and efficacy based on a comprehensive comparability exercise.1
A biological product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components and there are no clinically meaningful differences between biosimilar product and the reference product in terms of safety, purity, and potency of the product2.
A biosimilar is a version of an already licensed drug for which similarity has been proven in an extensive comparability exercise, encompassing physical, chemical, biological, and pharmacological properties, including efficacy and safety.1
Unlike small-molecule drugs, biologics are large, complex structures that are manufactured in living cells and have significant natural variability.
Based on their nature and manufacture, heterogeneity is commonplace in biologicals.
The focus of biosimilars development is not to establish benefit:risk but to demonstrate similarity to reference product.
Wolff-Holz E, Burgos G, et al. ESMO Open 2018;3:e000420
Biosimilarity is demonstrated through extensive structural and functional comparability studies and a tailored clinical program
Wolff-Holz E, Burgos G, et al. ESMO Open 2018; 3.e000420
Other biologic properties
Adapted from: Declerck P and Farouk Rezk M. Rheumatology (Oxford) 2017;56:iv4–13
example of quality
attributes of a biosimilar
monoclonal antibody candidate
Adapted from: Schiestl M, Li J, et al. Biologicals 2014;42:128–132
Each step should rely on the most advanced state-of-the-art capabilities
No step can refute/ overcome significant differences in preceding steps
All three steps must be satisfied to demonstrate biosimilarity
Consensus Information Paper 2019. Biosimilars in the EU. Information guide for healthcare professionals.
“The study population should generally be representative of approved therapeutic indication(s) of the reference product and be sensitive for detecting potential differences between the biosimilar and the reference”
Adapted from EMA Guidelines on similar biologic medicinal products, Dec 2014
EMA. Guideline on similar biological medicinal products. 18 December 2014. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-2.pdf, accessed 15 March 2021
The regulatory process of granting a clinical indication to a medicine without own/new clinical efficacy and safety data to support that indication
When biosimilar comparability has been demonstrated in one indication, extrapolation of clinical data to other indications of the reference product could be acceptable, but needs to be scientifically justified1
If the “total evidence” in the biosimilar application supports a demonstration of the biosimilarity for at least one of the reference product’s indications, then it is possible for the biosimilar manufacturer to use data and information to scientifically justify approval for other indications that were not directly studied by the biosimilar manufacturer2
Weise M, Kurki P, et al. Blood 2014;124:3191–6