Difference between innovator and generic drugs MCQs With Answer

Understanding the difference between innovator and generic drugs is essential for B. Pharm students preparing for pharmacy practice and regulatory roles. This concise, keyword-rich introduction highlights innovator drug, generic drug, bioequivalence, ANDA, patent protection, therapeutic equivalence, excipients, formulation differences, stability, and regulatory approval pathways. Learn how innovator products result from discovery, clinical trials and data exclusivity, while generics rely on demonstrated bioequivalence, manufacturing controls and approved labeling to ensure comparable safety and efficacy. A deeper grasp of these concepts supports quality control, substitution policies, pharmacokinetics, and post-marketing surveillance in real-world pharmacy practice. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary regulatory requirement for approval of a small-molecule generic drug in many jurisdictions?

• Submission of full clinical efficacy and safety trials
• Demonstration of bioequivalence to the reference listed drug
• Proof of novel mechanism of action
• Long-term pharmacovigilance data

Correct Answer: Demonstration of bioequivalence to the reference listed drug

Q2. How is an “innovator drug” best defined?

• A drug made by multiple manufacturers after patent expiry
• The original marketed product developed through discovery and clinical trials
• A non-prescription over-the-counter medicine
• An undocumented traditional remedy

Correct Answer: The original marketed product developed through discovery and clinical trials

Q3. Which regulatory application is typically submitted in the USA to seek approval for a generic drug?

• NDA (New Drug Application)
• BLA (Biologics License Application)
• ANDA (Abbreviated New Drug Application)
• MAA (Marketing Authorization Application)

Correct Answer: ANDA (Abbreviated New Drug Application)

Q4. What is the standard bioequivalence acceptance range used by FDA for Cmax and AUC 90% confidence intervals?

• 70–130%
• 75–133%
• 80–125% (90% confidence interval for geometric mean ratio)
• 90–110%

Correct Answer: 80–125% (90% confidence interval for geometric mean ratio)

Q5. Which study directly compares pharmacokinetic parameters between a generic and its reference drug?

• Therapeutic equivalence trial
• Bioequivalence study
• Stability study
• Post-marketing surveillance study

Correct Answer: Bioequivalence study

Q6. Which of the following is NOT typically required for approval of a generic small-molecule drug?

• Demonstration of bioequivalence
• Quality (CMC) documentation
• Large-scale Phase III clinical efficacy trials
• Approved labeling consistent with the reference drug

Correct Answer: Large-scale Phase III clinical efficacy trials

Q7. What does Reference Listed Drug (RLD) mean in generic drug development?

• The cheapest marketed alternative
• The innovator product used as the standard for comparison
• A biosimilar comparator
• An unapproved compound used in research

Correct Answer: The innovator product used as the standard for comparison

Q8. What is meant by “therapeutic equivalence” between two drug products?

• They have identical excipients
• They are pharmaceutically equivalent and expected to have the same clinical effect
• They are manufactured in the same facility
• They share the same price

Correct Answer: They are pharmaceutically equivalent and expected to have the same clinical effect

Q9. Which category of products is generally NOT considered a conventional small-molecule generic?

• Oral tablets
• Parenteral small-molecule injections
• Biologicals and biosimilars
• Topical creams with simple APIs

Correct Answer: Biologicals and biosimilars

Q10. What is the typical patent term for new drugs from filing in many jurisdictions?

• 10 years from approval
• 20 years from filing
• 5 years from first marketing
• Indefinite until withdrawn

Correct Answer: 20 years from filing

Q11. What is the main purpose of data exclusivity for innovator drugs?

• To prevent generic manufacturers from using the innovator’s clinical trial data for a defined period
• To extend the patent by 20 years
• To allow generics to be marketed sooner
• To substitute clinical trials with in vitro tests

Correct Answer: To prevent generic manufacturers from using the innovator’s clinical trial data for a defined period

Q12. A BCS-based biowaiver is most applicable to which Biopharmaceutics Classification System class?

• BCS Class II (low solubility, high permeability)
• BCS Class I (high solubility, high permeability)
• BCS Class IV (low solubility, low permeability)
• BCS Class III only

Correct Answer: BCS Class I (high solubility, high permeability)

Q13. Why are narrow therapeutic index (NTI) drugs a special concern for generic substitution?

• They are always over-the-counter
• Tiny changes in blood concentration can cause therapeutic failure or toxicity
• They never require bioequivalence studies
• They are always biologics

Correct Answer: Tiny changes in blood concentration can cause therapeutic failure or toxicity

Q14. Which statement about excipients in generic formulations is correct?

• Generics must use identical excipients as the innovator
• Excipients can differ but must not affect bioequivalence or safety
• Any new excipient is allowed without review
• Excipients are considered active ingredients

Correct Answer: Excipients can differ but must not affect bioequivalence or safety

Q15. Which pharmacokinetic parameter primarily reflects the rate of absorption?

• Cmax (maximum concentration)
• Tmax (time to reach Cmax)
• AUC (area under the curve)
• Clearance

Correct Answer: Tmax (time to reach Cmax)

Q16. What critical element is NOT part of an ANDA submission?

• Bioequivalence data
• Manufacturing and quality information (CMC)
• New clinical safety and efficacy trials for the same indication
• Proposed labeling consistent with the reference drug

Correct Answer: New clinical safety and efficacy trials for the same indication

Q17. Which analytical test is essential to confirm the active pharmaceutical ingredient (API) in a generic batch?

• Dissolution of placebo
• Identity and assay (potency) of the API by validated method
• Organoleptic testing only
• Packaging visual inspection only

Correct Answer: Identity and assay (potency) of the API by validated method

Q18. Innovator companies primarily invest in which development stages?

• Generic market competition only
• Discovery, preclinical research and Phase I–III clinical trials
• Retail distribution logistics only
• Post-marketing surveillance exclusively

Correct Answer: Discovery, preclinical research and Phase I–III clinical trials

Q19. When is a generic manufacturer generally allowed to market a generic product without patent infringement?

• Immediately after innovator approval
• Only after patent expiry or successful patent challenge
• Only if they change the API
• After 50 years from innovator approval

Correct Answer: Only after patent expiry or successful patent challenge

Q20. Which reference publication lists therapeutic equivalence evaluations for approved drugs in the USA?

• The Green Journal
• The Orange Book
• The British Pharmacopoeia
• The European Pharmacopoeia

Correct Answer: The Orange Book

Q21. For modified-release generic formulations, regulators often require:

• No additional studies beyond simple assay
• Additional in vivo bioequivalence studies and in vitro dissolution profiling
• Only a stability report
• Exclusive reliance on innovator manufacturing records

Correct Answer: Additional in vivo bioequivalence studies and in vitro dissolution profiling

Q22. What does polymorphism in a drug substance refer to?

• Different salt forms only
• Different crystalline forms of the same chemical substance
• Different brands of the same drug
• Changes in capsule color

Correct Answer: Different crystalline forms of the same chemical substance

Q23. What is the primary role of post-marketing surveillance for both innovator and generic drugs?

• To increase the drug price
• To monitor adverse events and long-term safety in real-world use
• To reduce manufacturing quality checks
• To avoid regulatory inspections

Correct Answer: To monitor adverse events and long-term safety in real-world use

Q24. Which statement best differentiates biosimilars from small-molecule generics?

• Biosimilars are chemically identical to innovator biologics
• Biosimilars are highly similar but not identical and require comparability and immunogenicity testing
• Biosimilars require no regulatory approval
• Biosimilars are always interchangeable with innovator biologics

Correct Answer: Biosimilars are highly similar but not identical and require comparability and immunogenicity testing

Q25. Why are generic medicines typically less expensive than innovator medicines?

• Generics use lower quality APIs
• Lower cost due to lack of original R&D expenses and increased market competition
• Because generics are illegal
• Because generics skip quality testing

Correct Answer: Lower cost due to lack of original R&D expenses and increased market competition

Q26. Which regulatory authority is the central drug regulator in India responsible for approving generics?

• EMA (European Medicines Agency)
• CDSCO (Central Drugs Standard Control Organization)
• FDA (Food and Drug Administration)
• MHRA (Medicines and Healthcare products Regulatory Agency)

Correct Answer: CDSCO (Central Drugs Standard Control Organization)

Q27. What does the term “interchangeability” mean in the context of generic drugs?

• A generic can be substituted for the innovator without any expectation of similar outcome
• The generic can be substituted for the innovator product without significant risk of reduced efficacy or increased adverse effects
• Only the manufacturer can change the formulation
• It means the products must have different active ingredients

Correct Answer: The generic can be substituted for the innovator product without significant risk of reduced efficacy or increased adverse effects

Q28. Bioequivalence is established when which statistical criterion is met?

• The mean ratio for AUC is exactly 100%
• The 95% confidence interval of the difference lies within 70–130%
• The 90% confidence interval of the geometric mean ratio for AUC and Cmax lies within 80–125%
• No statistical analysis is required

Correct Answer: The 90% confidence interval of the geometric mean ratio for AUC and Cmax lies within 80–125%

Q29. Which labeling requirement is generally expected for an approved generic drug?

• Completely different indications from the innovator
• Same indications and dosing as the reference listed drug unless supported by evidence
• No active ingredient disclosure
• Marketing claims not based on approval

Correct Answer: Same indications and dosing as the reference listed drug unless supported by evidence

Q30. What is the main purpose of dissolution testing in generic drug development?

• To determine packaging color
• To ensure consistent drug release and predict in vivo performance as part of quality control and potential biowaiver justification
• To replace bioequivalence studies for all drugs
• To assess microbial contamination only

Correct Answer: To ensure consistent drug release and predict in vivo performance as part of quality control and potential biowaiver justification

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