EMA (European Medicines Agency)
A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product (reference medicinal product) in the European Economic Area (EEA).
Similarity to the reference medicinal product in terms of quality characteristics, biological activity, safety and efficacy based on a comprehensive comparability exercise needs to be established.1
FDA (Food and Drug Administration – US)
A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.2
BioSim (Spanish Biosimilar Medicines Association)
A biosimilar medicine (or similar biological medicine) is a biological medicine that contains a version of the active substance of an original biological product (reference product) for which equivalence has been demonstrated. The biosimilar medicine is approved for all, or some of the indications of the reference product, and its posology and route of administration must be the same. Equivalence with the reference product must be established by means of an exhaustive “comparability exercise”.
The object of this exercise is to demonstrate that the slight physicochemical differences that exist between the two products have no significant impact on the quality, efficacy and safety of the biosimilar, implying that the active substance of both medicinal products is essentially the same.3
- European Medicines Agency: Guideline on similar biological medicinal products. EMEA/CHMP/437/04 Rev. 1. Available on: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf.
- Food and Drug Administration: Information on Biosimilars. Available on: https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/.
- BioSim. The biosimilar medicines decalogue. Available on. Available: http://www.biosim.es/documentos/the-biosimilar-medicines-decalogue.pdf.