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Table 2 Comparisons between biosimilars and generics

From: What do oncologists need to know about biosimilar products?

Feature Biosimilars 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
  1. US the United States; FDA the Food and Drug Administration; EU the European Union; EMA the European Medicines Agency