2 Flashcards
What are biosimilars?
Biosimilars are biologic medical products highly similar to already approved reference biologics, with no clinically meaningful differences in safety, purity, or potency.
True or False: Biosimilars are identical to their reference products.
False
What is the main regulatory body in the United States that oversees biosimilars?
The Food and Drug Administration (FDA)
Fill in the blank: Biosimilars can only be approved after the reference product has received ______ approval.
market
Which of the following is a requirement for biosimilar approval?
Demonstrating similarity in terms of structure, biological activity, and clinical efficacy.
What is the primary benefit of using biosimilars?
Cost savings compared to reference biologics.
Name one of the challenges in developing biosimilars.
The complexity of biologic molecules makes characterization difficult.
True or False: Once a biosimilar is approved, it can be automatically substituted for the reference product without prescriber approval.
False
What is the term for the original biologic product that a biosimilar is compared against?
Reference product
Which type of therapy do biosimilars primarily fall under?
Biologic therapy
What is the significance of the 351(k) pathway in the context of biosimilars?
It is the regulatory pathway established by the FDA for the approval of biosimilars.
True or False: Biosimilars must undergo the same extensive clinical trials as the reference product.
False
What are interchangeable biosimilars?
Biosimilars that meet additional standards to allow them to be substituted for the reference product without the intervention of the prescriber.
Fill in the blank: The European Medicines Agency (EMA) has been regulating biosimilars since ______.
2006
What is the importance of pharmacovigilance in the context of biosimilars?
It ensures ongoing safety monitoring of biosimilars post-approval.
Which class of drugs can biosimilars be categorized under?
Monoclonal antibodies, hormones, and vaccines.
What is the main difference between generics and biosimilars?
Generics are identical copies of small-molecule drugs, while biosimilars are similar but not identical to biologic drugs.
What does the term ‘extrapolation’ refer to in biosimilar approvals?
The ability to use data from one indication to approve the biosimilar for other indications of the reference product.
True or False: The approval of biosimilars leads to increased competition in the market.
True
What is a common misconception about biosimilars?
That they are cheap copies of biologics.
What role do healthcare providers play in the adoption of biosimilars?
They help educate patients and make decisions about treatment options.
Fill in the blank: The first biosimilar approved in the US was ______.
Zarxio
What is the purpose of conducting a pharmacokinetic study for a biosimilar?
To compare the absorption, distribution, metabolism, and excretion of the biosimilar to the reference product.
What is the significance of the term ‘no clinically meaningful differences’ in biosimilar evaluation?
It ensures that the biosimilar performs similarly to the reference product in terms of safety and efficacy.
