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.
- The guidelines of the World Health Organization (WHO) adopt the term "Similar Biotherapeutic Products (SBPs)"1 [October 2009].
- The term "Biosimilar Biological Products"2 is used by the United States Food and Drug Administration (USFDA), and defines biosimilarity to mean “that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components” and that “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.
- The term "Similar Biological Medicinal Products (SBMP)"3 has been adopted by the European Medicines Agency (EMA), which defines a biosimilar as a biological medicinal product that contains a version of the active substance of an already authorised original biological medicinal product (reference medicinal product) in the European Economic Area. 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.
- The Central Drugs Standard Control Organization (CDSCO), the national regulatory authority for approval in drugs in India has adopted the term “Similar Biologics”4 [March 2016]. Thus, a similar biologic product is that which is similar in terms of quality, safety and efficacy to an approved Reference Biological product based on comparability.
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”.
- EMA = European Medicines Agency
- SBMP = similar biological medicinal products
- SBPs = similar biotherapeutic products
- WHO = World Health Organization
- 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.
- Food and Drug Administration, 2015.Scientific Considerations in demonstrating Biosimilarity to a Reference Product. Food and Drug Administration.
- European Medicines Agency, 2014. guideline on similar biological medicinal products. European Medicines Agency.
- Central Drugs Standard Control Organization, 2016. Guidelines on Similar Biologics. Central Drugs Standard Control Organization