2 Flashcards

1
Q

What are biosimilars?

A

Biosimilars are biologic medical products highly similar to already approved reference biologics, with no clinically meaningful differences in safety, purity, or potency.

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2
Q

True or False: Biosimilars are identical to their reference products.

A

False

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3
Q

What is the main regulatory body in the United States that oversees biosimilars?

A

The Food and Drug Administration (FDA)

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4
Q

Fill in the blank: Biosimilars can only be approved after the reference product has received ______ approval.

A

market

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5
Q

Which of the following is a requirement for biosimilar approval?

A

Demonstrating similarity in terms of structure, biological activity, and clinical efficacy.

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6
Q

What is the primary benefit of using biosimilars?

A

Cost savings compared to reference biologics.

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7
Q

Name one of the challenges in developing biosimilars.

A

The complexity of biologic molecules makes characterization difficult.

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8
Q

True or False: Once a biosimilar is approved, it can be automatically substituted for the reference product without prescriber approval.

A

False

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9
Q

What is the term for the original biologic product that a biosimilar is compared against?

A

Reference product

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10
Q

Which type of therapy do biosimilars primarily fall under?

A

Biologic therapy

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11
Q

What is the significance of the 351(k) pathway in the context of biosimilars?

A

It is the regulatory pathway established by the FDA for the approval of biosimilars.

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12
Q

True or False: Biosimilars must undergo the same extensive clinical trials as the reference product.

A

False

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13
Q

What are interchangeable biosimilars?

A

Biosimilars that meet additional standards to allow them to be substituted for the reference product without the intervention of the prescriber.

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14
Q

Fill in the blank: The European Medicines Agency (EMA) has been regulating biosimilars since ______.

A

2006

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15
Q

What is the importance of pharmacovigilance in the context of biosimilars?

A

It ensures ongoing safety monitoring of biosimilars post-approval.

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16
Q

Which class of drugs can biosimilars be categorized under?

A

Monoclonal antibodies, hormones, and vaccines.

17
Q

What is the main difference between generics and biosimilars?

A

Generics are identical copies of small-molecule drugs, while biosimilars are similar but not identical to biologic drugs.

18
Q

What does the term ‘extrapolation’ refer to in biosimilar approvals?

A

The ability to use data from one indication to approve the biosimilar for other indications of the reference product.

19
Q

True or False: The approval of biosimilars leads to increased competition in the market.

A

True

20
Q

What is a common misconception about biosimilars?

A

That they are cheap copies of biologics.

21
Q

What role do healthcare providers play in the adoption of biosimilars?

A

They help educate patients and make decisions about treatment options.

22
Q

Fill in the blank: The first biosimilar approved in the US was ______.

A

Zarxio

23
Q

What is the purpose of conducting a pharmacokinetic study for a biosimilar?

A

To compare the absorption, distribution, metabolism, and excretion of the biosimilar to the reference product.

24
Q

What is the significance of the term ‘no clinically meaningful differences’ in biosimilar evaluation?

A

It ensures that the biosimilar performs similarly to the reference product in terms of safety and efficacy.