Biologic medicines for cardiovascular diseases MCQs With Answer

Introduction

This quiz collection on “Biologic medicines for cardiovascular diseases” is designed for M.Pharm students preparing for the Biological Evaluation of Drug Therapy course. It covers mechanisms, clinical applications, pharmacokinetics, immunogenicity, production, regulatory aspects and safety considerations of biologics used in cardiovascular medicine — including monoclonal antibodies, siRNA/antisense therapies, recombinant proteins, peptides and thrombolytics. Questions probe deeper concepts such as assay selection for potency and anti‑drug antibodies, half‑life extension strategies, cell lines for production, and biosimilar/interchangeability requirements. Use these MCQs to strengthen critical understanding needed for exam success and for rational evaluation of biologic therapies in cardiovascular practice.

Q1. Which of the following best describes the mechanism of PCSK9 monoclonal antibodies like evolocumab and alirocumab?

• They prevent LDL receptor degradation, increasing hepatic LDL uptake
• They inhibit HMG‑CoA reductase to reduce cholesterol synthesis
• They increase intestinal cholesterol excretion by blocking NPC1L1
• They activate lipoprotein lipase to clear triglyceride‑rich lipoproteins

Correct Answer: They prevent LDL receptor degradation, increasing hepatic LDL uptake

Q2. Inclisiran lowers LDL‑C by which molecular mechanism?

• Monoclonal antibody that binds circulating PCSK9
• Small‑molecule inhibitor of PCSK9 secretion
• siRNA that degrades PCSK9 mRNA in hepatocytes
• Antisense oligonucleotide that blocks APOB translation

Correct Answer: siRNA that degrades PCSK9 mRNA in hepatocytes

Q3. Mipomersen is a biologic used in severe hypercholesterolemia. What is its primary target and mechanism?

• ApoB protein — monoclonal antibody neutralization
• ApoB mRNA — antisense oligonucleotide reducing apoB synthesis
• PCSK9 mRNA — siRNA‑mediated silencing
• HMG‑CoA reductase — enzyme inhibition

Correct Answer: ApoB mRNA — antisense oligonucleotide reducing apoB synthesis

Q4. Which of the following is a recombinant tissue plasminogen activator used for thrombolysis in acute myocardial infarction and stroke?

• Alteplase (recombinant tPA)
• Streptokinase (bacterial protein)
• Urokinase (endogenous serine protease)
• Heparin (glycosaminoglycan anticoagulant)

Correct Answer: Alteplase (recombinant tPA)

Q5. Which direct thrombin inhibitor is a recombinant hirudin derivative produced as a biologic anticoagulant?

• Argatroban (small molecule)
• Dabigatran (oral small molecule)
• Lepirudin (recombinant hirudin)
• Warfarin (vitamin K antagonist)

Correct Answer: Lepirudin (recombinant hirudin)

Q6. Eptifibatide is classified as which type of biologic agent used to prevent platelet aggregation?

• Monoclonal antibody against GPIIb/IIIa
• Cyclic peptide GPIIb/IIIa receptor antagonist
• Small‑molecule P2Y12 inhibitor
• Recombinant tissue plasminogen activator

Correct Answer: Cyclic peptide GPIIb/IIIa receptor antagonist

Q7. Fusion of a therapeutic protein to an Fc domain prolongs half‑life primarily by engaging which pathway?

• Complement activation cascade to protect the protein
• Fcγ receptor‑mediated increased cellular uptake
• Neonatal Fc receptor (FcRn) recycling and decreased lysosomal degradation
• Toll‑like receptor signalling to induce protein expression

Correct Answer: Neonatal Fc receptor (FcRn) recycling and decreased lysosomal degradation

Q8. The major clinical consequence of anti‑drug antibody (ADA) formation against a therapeutic biologic is most often which of the following?

• Immediate cytokine storm in all patients
• Neutralization of drug activity leading to loss of efficacy
• Always improved therapeutic potency
• Complete prevention of any adverse events

Correct Answer: Neutralization of drug activity leading to loss of efficacy

Q9. Which mammalian cell line is most commonly used for production of complex, glycosylated therapeutic monoclonal antibodies?

• Escherichia coli
• Saccharomyces cerevisiae
• Chinese hamster ovary (CHO) cells
• Insect Sf9 cells exclusively

Correct Answer: Chinese hamster ovary (CHO) cells

Q10. For detecting functional neutralizing antibodies that block a biologic’s activity, which assay format is considered the most appropriate regulatory “gold standard”?

• ELISA binding assay only
• Surface plasmon resonance (SPR) binding analysis
• Cell‑based biological neutralization assay
• Western blot for drug‑bound complexes

Correct Answer: Cell‑based biological neutralization assay

Q11. Which modification is commonly used to increase the circulating half‑life of peptide and protein biologics and can also reduce dosing frequency?

• PEGylation of the molecule
• Decreasing molecular weight to enhance renal clearance
• Removal of glycosylation sites
• Formulation in hypertonic solution

Correct Answer: PEGylation of the molecule

Q12. Which pharmacodynamic marker is most appropriate to monitor efficacy of PCSK9 inhibitors in clinical studies?

• C‑reactive protein (CRP)
• Cardiac troponin I
• International normalized ratio (INR)
• Low‑density lipoprotein cholesterol (LDL‑C)

Correct Answer: Low‑density lipoprotein cholesterol (LDL‑C)

Q13. The regulatory approval of a biosimilar product primarily relies on which principle?

• Identical primary sequence only, no comparability required
• Totality of evidence including analytical, nonclinical and clinical comparability
• Only clinical efficacy trials in large patient populations
• Demonstration of identical manufacturing process to the reference

Correct Answer: Totality of evidence including analytical, nonclinical and clinical comparability

Q14. Which of the following is a monoclonal antibody fragment used to block platelet GPIIb/IIIa and reduce periprocedural thrombosis?

• Tirofiban (small molecule)
• Abciximab (monoclonal antibody/Fab)
• Clopidogrel (prodrug P2Y12 inhibitor)
• Heparin (polysaccharide anticoagulant)

Correct Answer: Abciximab (monoclonal antibody/Fab)

Q15. Which RNAi‑based biologic has been approved for treatment of transthyretin-mediated (TTR) amyloidosis and acts by silencing hepatic TTR production?

• Inotersen (antisense oligonucleotide)
• Patisiran (siRNA packaged in lipid nanoparticles)
• Tafamidis (small‑molecule TTR stabilizer)
• Digoxin (cardiac glycoside)

Correct Answer: Patisiran (siRNA packaged in lipid nanoparticles)

Q16. Which adverse effect is the most serious and clinically limiting safety concern associated with systemic thrombolytic biologics?

• Intracranial hemorrhage and major bleeding
• Mild transient rash only
• Minimal renal clearance leading to accumulation
• Always causes severe hepatotoxicity

Correct Answer: Intracranial hemorrhage and major bleeding

Q17. Which recombinant biologic natriuretic peptide has been used in acute decompensated heart failure to promote vasodilation and natriuresis?

• Nesiritide (recombinant B‑type natriuretic peptide)
• ANP‑inhibitor monoclonal antibody
• Sacubitril (neprilysin inhibitor small molecule)
• Dabigatran (oral direct thrombin inhibitor)

Correct Answer: Nesiritide (recombinant B‑type natriuretic peptide)

Q18. Which engineering strategy is commonly used to reduce the immunogenicity of therapeutic monoclonal antibodies for chronic cardiovascular indications?

• Use of fully murine antibody sequences
• Humanization or development of fully human antibody sequences
• Deliberate addition of foreign T‑cell epitopes
• Frequent high‑dose bolus administration to induce tolerance

Correct Answer: Humanization or development of fully human antibody sequences

Q19. In the United States, achieving an “interchangeable” designation for a biosimilar product typically requires which additional evidence beyond biosimilarity?

• No additional data — biosimilarity alone is sufficient for interchangeability
• Clinical switching studies that demonstrate safety and efficacy when alternating with the reference product
• Only in vitro analytical similarity data are required
• Proof of identical manufacturing site and process to the originator

Correct Answer: Clinical switching studies that demonstrate safety and efficacy when alternating with the reference product

Q20. Which coagulation assay is particularly sensitive and specific for measuring the anticoagulant effect of direct thrombin inhibitors (e.g., bivalirudin, dabigatran)?

• Prothrombin time / INR
• Activated partial thromboplastin time (aPTT) only
• Ecarin clotting time (ECT)
• D‑dimer concentration

Correct Answer: Ecarin clotting time (ECT)

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