Use of the term Biosimilar

Given the complexity of biopharmaceuticals, there is, as yet, no common terminology describing “similar” versions of this important class of pharmaceutical products. Different regulatory agencies have adopted different specific nomenclatures for what is widely regarded as “biosimilars”, a few of which are reproduced below.

As other regulatory agencies around the world establish guidelines for “biosimilar” approval, the debate on the issue of nomenclature continues to evolve.

However notwithstanding any nomenclature/definitions adopted, or to be adopted, by various regulatory agencies, the most common description in the industry for this class of products is "biosimilar/s". Hence for the purposes of the enclosed material we use of the term “biosimilar/s”.


  1. World Health Organization. Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). WHO Expert Committee on Biological Standardization, Sixtieth report (19-23 October 2009). WHO Technical Report Series No. 977, 2013 – Annex.
  2. Food and Drug Administration, 2015.Scientific Considerations in demonstrating Biosimilarity to a Reference Product. Food and Drug Administration.
  3. European Medicines Agency, 2014. guideline on similar biological medicinal products. European Medicines Agency.
  4. Central Drugs Standard Control Organization, 2016. Guidelines on Similar Biologics. Central Drugs Standard Control Organization