Post Test: Biosimilars vs. Biologics. vs. Generics: Key Concepts

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Question 1 of 4

1. Question
Which of the following is the correct definition of the term “biosimilar”?
- A biologic medication that is highly similar to, and has no clinically meaningful differences from, an existing FDA-approved biologic
- A medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use
- New drugs designed from existing peptide or protein-based therapeutics that improve their properties such as affinity and selectivity for the target epitope, and stability against degradation
- A product containing living organisms that are generally more complex than those of other medications
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Question 2 of 4

2. Question
What makes an interchangeable biosimilar unique?
- It has been shown to be an exact copy of the reference product in at least 2 clinical trials
- Its approval is based on additional data about the impact of switching or alternating between the interchangeable product and the reference product
- It is at least 50% less expensive than its reference product
- It has been shown to be an improved adaptation of the originator biologic through both clinical and real-world trials
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Question 3 of 4

3. Question
Which of the following would be considered an acceptable naming convention for an approved biosimilar?
- Adalimumab-safe
- Etanercept-nyr
- Rituximab-aldr
- Cimzia-glpe
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Question 4 of 4

4. Question
Which of the following is not among the ways in which a biosimilar differs from a generic product?
- Biosimilars are typically manufactured from living sources while generics are manufactured through chemical synthesis
- Biosimilars involve smaller, simpler molecules than generics
- Biosimilars may have inherent variability between batches while generics must have an identical active ingredient between lots
- Biosimilars must demonstrate no clinically meaningful differences from the reference product while generics must demonstrate bioequivalence to the reference product
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Post Test: Biosimilars vs. Biologics. vs. Generics: Key Concepts

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