Table 1.

Worldwide regulatory definitions of biosimilars [4]

Regulatory authority	Definition	Reference
The European Medicines Agency (EMA)	A biosimilar is a biological medicine highly similar to another already approved biological medicine (the ‘reference medicine’) (Biosimilars are approved according to the same standards of pharmaceutical quality, safety, and efficacy that apply to all biological medicines)	The European Medicines Agency. Biosimilar Medicines
US Food and Drug Administration (US-FDA)	A biosimilar is a biologic product that is highly similar to a US-licensed reference biological product, notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the RP in terms of the safety, purity, and potency of the product	42 U.S. Code § 262 (i) (2)—Regulation of biological products FDA Guidance for Industry: Questions and Answers regarding BPCIA (2015)
The Japanese Pharmaceuticals and Medical Devices Agency (Jp-PMDA)	A biosimilar is a follow-on biological medicinal product (FOBMP) that is a new biotechnological medicinal product developed to be similar to an already licensed, biotechnology medical product (reference biological product; RBP) and is developed on the basis of data that demonstrate comparability between the FOBMP and the RBP with respect to quality, safety, and efficacy or other relevant data	Japan Generic Medicines Association Nov 25, 2010 Interim Translation of Notification LED, PFSB, MHLW; Yakushokushinsa No. 0304007 (Mar 4, 2009)
The World Health Organization (WHO)	A biosimilar is a similar biotherapeutic product (SBP), defined as “a biotherapeutic product, which is similar in terms of quality, safety, and efficacy to an already licensed reference biotherapeutic product”	WHO Guidelines on Evaluation of Similar Biotherapeutic Products (2009)