Biosimilars and therapeutic equivalence define and differences Flashcards
(15 cards)
What are biosimilars?
Biosimilars are biologic medical products highly similar to an already approved reference biologic, with no clinically meaningful differences in safety, purity, or potency.
True or False: Biosimilars are identical to their reference products.
False
Fill in the blank: Biosimilars must demonstrate __________ to the reference product in terms of efficacy and safety.
similarity
What is therapeutic equivalence?
Therapeutic equivalence refers to the situation where two drugs have the same therapeutic effect and can be used interchangeably in clinical settings.
Multiple Choice: Which of the following is a key requirement for biosimilars? A) Must have the same active ingredient, B) Must be manufactured in the same facility, C) Must be produced by the same process.
A) Must have the same active ingredient
True or False: All biosimilars can be considered therapeutically equivalent to their reference products.
False
What is the main regulatory agency for biosimilars in the United States?
The Food and Drug Administration (FDA)
Fill in the blank: The approval process for biosimilars includes extensive __________ studies.
comparative
Multiple Choice: Which statement is true about biosimilars? A) They can be substituted for the reference product without physician approval, B) They require new clinical trials to establish equivalence, C) They are usually less expensive than their reference products.
C) They are usually less expensive than their reference products.
What is one key difference between biosimilars and generic drugs?
Biosimilars are not identical copies of their reference products, while generic drugs are chemically identical to their brand-name counterparts.
True or False: Biosimilars can differ in inactive ingredients from their reference products.
True
What does the term ‘interchangeability’ mean in the context of biosimilars?
Interchangeability means that a biosimilar can be substituted for the reference product without the intervention of the prescriber.
Fill in the blank: Clinical studies for biosimilars focus on __________ and safety in the target patient population.
efficacy
Multiple Choice: Which of the following is NOT a requirement for a biosimilar? A) Same mechanism of action, B) Same route of administration, C) Same packaging.
C) Same packaging.
What is the significance of the term ‘no clinically meaningful differences’ in biosimilars?
It indicates that any differences in the biosimilar compared to the reference product do not impact patient safety or efficacy.
