Table 1.

Definitions and Terminology Used for Biosimilars and Generics.

Biologic(al)	An approved product consisting of proteins, nucleic acids, or combinations thereof, or living entities such as cells and tissues, isolated from natural sources and produced by biotechnological processes.
Reference (originator/innovator) biologic product	The single, already approved biological product to which a proposed biosimilar is compared.
Biosimilar17,18	A biological medicine highly similar to another already approved biological medicine in terms of structure, biological activity, efficacy, safety and immunogenicity profile
Generic drug	Chemically synthesized small- or low-molecular-weight compounds consist of a simple, well-defined structure that is independent of the manufacturing process and can be easily fully characterized.