Dictionary
The Dictionary provides concise definitions of health economics terms, arranged alphabetically for quick reference. Use it to understand unfamiliar terminology or confirm the meaning of a specific term.
B
- BiosimilarFollow-on Biologic, Subsequent Entry Biologic
- A biological product highly similar to an approved reference biologic, with no clinically meaningful differences in safety, purity, or potency.
- Biosimilar ApprovalBiosimilar Authorisation, Biosimilar Licensing
- The regulatory process by which a biosimilar, highly similar to an approved reference biologic with no meaningful clinical differences, gains marketing authorisation.
- Biosimilar PricingBiosimilar Price Strategy, Biosimilar Discounting
- The pricing strategies applied to biosimilar products, typically launched at a discount to the reference biologic's price to encourage uptake.
- Biosimilar SubstitutionBiosimilar Interchange, Biosimilar Switching
- Dispensing a biosimilar in place of a prescribed reference biologic without prescriber intervention, permitted only for biosimilars with interchangeability designation.
- Biosimilar UptakeBiosimilar Adoption, Biosimilar Penetration
- The rate at which a biosimilar is adopted into clinical use after market entry, influenced by pricing, physician familiarity, and payer policy.
C
- Comparability StudyComparability Exercise, Biosimilarity Study
- A study demonstrating that a biosimilar is highly similar to its reference biologic, with no clinically meaningful differences in safety, purity, and potency.
D
- Data ExclusivityRegulatory Data Protection, Data Protection Period
- A period during which regulators cannot rely on an originator's trial data to approve a generic or biosimilar competitor, distinct from patent protection.
- Drug SubstitutionMedicine Substitution, Product Interchange
- The replacement of one medicine with another regarded as equivalent, such as a generic or biosimilar for an originator product, commonly to lower cost.
I
- Interchangeability DeterminationInterchangeability Designation, FDA Interchangeability, Interchangeability Status
- A regulatory designation for certain biosimilars indicating they can be substituted for the reference biologic at pharmacy level without prescriber involvement.
M
- Market ExclusivityMarketing Exclusivity, Data Exclusivity Period
- A period during which regulators will not approve a competing generic or biosimilar, arising from patent protection, regulatory provisions, or both.
P
- Patent ChallengePatent Litigation, Patent Dispute
- A legal action by a generic or biosimilar manufacturer disputing a reference product's patent validity, often a precursor to earlier market entry.
- Price ErosionPrice Decline, Post-Patent Erosion
- The gradual decline in a drug's price over time, most commonly following generic or biosimilar competition after patent exclusivity is lost.
R
- Reference ProductOriginator Product, Reference Biologic
- The originally approved biologic against which a biosimilar is compared during development, required to show high similarity with no meaningful clinical differences.