Copy biologic/Alternative biologic—Version of an off-patent biologic that is not subjected to the rigourous assessment required for biosimilars in highly regulated markets such as the EU and USA.
Follow-on protein/Follow-on biologic—Umbrella term encompassing biosimilars and copy biologics (any "copy" of an off-patent originator biologic).
Similar biological medicinal product (SBMP)—A biosimilar.
Subsequent entry biologic (SEB)—A biosimilar (term used in Canada).
Biotechnology follow-on product—A biosimilar (term used in Japan).
Biocomparable—A biosimilar (term used in Mexico).
Biobetter/Second generation biologic—Biologic that has been altered structurally or functionally to improve its performance.
Me-too biologic—Targets same pathway as originator biologic but developed independently and is not compared to it.
Clinical and regulatory terms
Comparability testing (comparable [EU], highly similar [USA])—Comparison of a biosimilar to the originator medicine (reference) with the aim of establishing similarity in safety (including immunogenicity), efficacy, and quality.
Head-to-head comparison—A direct comparison of the properties of the biosimilar candidate to the originator in the same study.
Immunogenicity testing—A comparison of the immune response (e.g. development of specific antibodies, T-cell response, allergic reaction) triggered by a biosimilar candidate versus the originator medicine.
Interchangeability (also called: substitutability)—When switching between the use of a biosimilar and the originator medicine does not impact the efficacy and safety (including immunogenicity). “To be deemed interchangeable with the reference product, the biosimilar is expected to produce the same clinical results in any given patient.”(USA)
Non-inferiority—Demonstration that the response to an investigational product is not clinically inferior to that of a comparator by a pre-specified margin.
Product drift—Changes in an originator product because of manufacturing alterations over time.
Product characterization—Establishing the comparability of a biosimilar candidate to the originator in terms of composition, size, structure, and bioactivity, as well as testing to rule out contamination.
Pharmacological characterization—Analyses comparing the absorption and elimination rates, bioequivalence range, therapeutic index, dose-response curves, and tissue-specific localization of a biosimilar candidate to the originator medicine.
Stability studies—Analyses of shelf-life and storage conditions of the biosimilar candidate over time.
Understanding Biosimilars answers key questions about biosimilars to prepare investigators and site staff for participation in clinical trials.