Breakthrough Biosimilars QUIZ

Biosimilars and their reference biologics have no clinically meaningful differences in safety, purity, and potency.

True

False

What is the definition of switch?

A. “Switch” refers to the authorization of a biosimilar for indications where clinical studies were not done.

B. “Switch” generally refers to a one-time change from a reference biologic drug to a biosimilar.

C. In Canada, the term “Switch” refers to the ability for a patient to be changed from one drug to another equivalent drug by a pharmacist.

D. “Switch” generally refers to a change in the efficacy of a biosimilar.

A biosimilar and its reference biologic share the same amino acid sequence and mechanism of action.

True

False

What are the benefits of biosimilars?

A. Reduced costs

B. Increased competition

C. Improved drug accessibility

D. All of the above

Health Canada approves the proprietary manufacturing process for the product itself based on set parameters each product batch must fall between. This way, any batch to batch variation is part of a normal and expected process which has been reviewed by Health Canada and falls between acceptable limits. What is the name of this concept?

What does HERZUMA consist of?

A. A monoclonal antibody

B. A polyclonal antibody

C. An antigen

D. None of the above

In Canada, the term interchangeability often refers to the ability for a patient to be changed from one drug to another equivalent drug by a pharmacist, without the intervention of the doctor who wrote the prescription.

True

False

Breakthrough Biosimilars QUIZ

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