Table 2 Comparisons between biosimilars and generics

Definitions

US FDA A biosimilar is a biological product that is highly similar to a licensed reference biological product notwithstanding minor differences in clinically inactive components; and 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

US FDA A generic drug is identical to a brand name drug in dosage, safety, strength, route of administration, quality, performance, and intended use

EU EMA A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product (reference medicinal product). Similarity to the reference medicinal product in terms of quality characteristics, biological activity, safety, and efficacy based on a comprehensive comparability exercise need to be established

EU EMA A generic medicine is a medicine that is developed to be the same as a medicine that has already been authorized (the “reference medicine”). It contains the same active substance(s) as the reference medicine, and it is used at the same dose(s) to treat the same disease(s) as the reference medicine

Manufacturing processes

Complex, as they are derived from living cells or organisms, sensitive to manufacturing changes

Simple, as produced by chemical synthesis

Immunogenicity

Immunogenic

Mostly non-immunogenic

Compared with original counterparts

Similar but not identical

Need to demonstrate comparability (i.e., no clinically meaningful differences) to its comparator (the reference drug)

Automatic substitution not recommended (some biosimilars might not carry all the same indications, especially if the reference biologics have multiple mechanisms of action)

Identical

Therapeutically equivalent

Allow automatic substitution