TABLE 2.

Terminology

Term	Definition
Generics Generic drugs	Generic drugs are identical (or bioequivalent) to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.
Biologics Biological products	Biological products are made from a variety of natural sources and are used to either treat or cure diseases and medical conditions, prevent diseases, or diagnose diseases. Biological products can be made of sugars, proteins, nucleic acids, or complex combinations of these substances or may be living entities such as cells and tissues.
Biosimilars Biosimilar products	Biosimilars are a type of biological product that is licensed (approved) by the FDA under section 351(k) of the PHS Act because they are highly similar to an already FDA-approved biological reference product and have been shown to have no clinically meaningful differences from the reference product. Minor differences in clinically inactive components are allowed, but there must be no clinically meaningful differences between the biosimilar and the reference product it was compared to in terms of the safety, purity, and potency of the product.
Follow-on biologics	This term is used to describe biological products designed to be similar to a biological reference product that has been approved under a pathway other than 351(k) of the PHS Act.
Reference products Reference biologics	These terms describe biological products approved by the FDA under section 351(k) of the PHS Act.
Interchangeable products	Interchangeable products are both biosimilar to their reference product and expected to produce the same clinical result as the reference product in any given patient. In addition, for a biological product that is administered more than once to an individual, the risk in alternating or switching between the biological product and the reference product in terms of safety or diminished effectiveness will not be greater than the risk of using the reference product without alternating or switching.
Automatic substitution	An interchangeable product that may be substituted for the reference product without the intervention of the HCP who prescribed the reference product (depending on local regulations).
Originator insulin Innovator insulin	These terms refer to the original, branded formulation of an insulin.
Noninferiority study	This term describes a study that aims to demonstrate that a biosimilar is not inferior to a reference insulin by more than a small prespecified amount.