Purple Book – biosimilars and biologics listing MCQs With Answer provides B. Pharm students an essential guide to regulatory listings, approval pathways, and safety monitoring for biologics and biosimilars. This short introduction covers Purple Book purpose, biosimilar versus reference biologic distinction, FDA listing practices, interchangeability criteria, and post-marketing pharmacovigilance concepts. Emphasis is on analytical similarity, clinical study requirements, 351(k) versus 351(a) pathways, extrapolation of indications, and practical implications for pharmacy practice and drug substitution. Keywords: Purple Book, biosimilars, biologics, FDA, interchangeability, reference product, 351(k), pharmacovigilance, regulatory listing, B. Pharm. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of the FDA Purple Book?
- To list approved small-molecule drugs and their bioequivalence ratings
- To provide a searchable list of licensed biological products, including biosimilars and interchangeable biologics
- To publish patent litigation outcomes for pharmaceuticals
- To list dietary supplements recognized as safe
Correct Answer: To provide a searchable list of licensed biological products, including biosimilars and interchangeable biologics
Q2. Which regulatory pathway is specifically used in the US to seek approval for a biosimilar?
- New Drug Application (NDA)
- Biologic License Application under section 351(a)
- Biologic License Application under section 351(k)
- Abbreviated New Drug Application (ANDA)
Correct Answer: Biologic License Application under section 351(k)
Q3. Which product is considered the “reference product” in biosimilar development?
- The biosimilar being developed
- An unrelated small-molecule drug
- The licensed biologic against which similarity is demonstrated
- A generic version of a biologic
Correct Answer: The licensed biologic against which similarity is demonstrated
Q4. What key evidence is required to demonstrate biosimilarity?
- Only clinical efficacy trials in multiple indications
- Comprehensive analytical comparison, nonclinical, and limited clinical studies
- Only pharmacovigilance data after marketing
- Only in vitro cell culture data
Correct Answer: Comprehensive analytical comparison, nonclinical, and limited clinical studies
Q5. What additional designation allows a biosimilar to be substituted at the pharmacy level in some jurisdictions?
- Reference product status
- Interchangeability designation
- Therapeutic equivalence rating
- Orphan drug designation
Correct Answer: Interchangeability designation
Q6. Which of the following best describes “interchangeability” under FDA guidance?
- A biosimilar that is less effective but cheaper than the reference product
- A biosimilar expected to produce the same clinical result and meets additional switching study requirements
- A product approved only for investigational use
- A generic small-molecule equivalent
Correct Answer: A biosimilar expected to produce the same clinical result and meets additional switching study requirements
Q7. Where can B. Pharm students access Purple Book listings?
- WHO website only
- European Medicines Agency database only
- U.S. Food and Drug Administration (FDA) website
- Pharmacy college intranet exclusively
Correct Answer: U.S. Food and Drug Administration (FDA) website
Q8. Which of the following is NOT typically included in Purple Book entries?
- Licensing pathway and approval date
- Interchangeability status
- Pricing and reimbursement details
- Reference product designation
Correct Answer: Pricing and reimbursement details
Q9. Extrapolation of indications for a biosimilar means:
- The biosimilar is approved for fewer indications than the reference product by default
- Approval for one indication automatically prohibits use in others
- Approval for additional indications can be granted without separate clinical trials when justified scientifically
- The biosimilar must run full trials for every indication
Correct Answer: Approval for additional indications can be granted without separate clinical trials when justified scientifically
Q10. Which study type is often required to support an interchangeability designation?
- Long-term animal toxicity studies only
- Multiple switching clinical studies demonstrating no increased risk
- Only in vitro analytical similarity tests
- Only single-dose pharmacokinetic studies in healthy volunteers
Correct Answer: Multiple switching clinical studies demonstrating no increased risk
Q11. The regulatory dossier for a biosimilar must demonstrate which of the following about impurities and glycosylation patterns?
- They can differ significantly from the reference product without justification
- They must be identical at the nucleotide sequence level
- Analytical comparability showing no clinically meaningful differences
- No data on impurities are required for biologics
Correct Answer: Analytical comparability showing no clinically meaningful differences
Q12. Which federal statute provides the legal basis for the Purple Book listings of biologics?
- Federal Food, Drug, and Cosmetic Act (FD&C Act) only
- Public Health Service Act (PHS Act)
- PATENT Act
- Medicare Modernization Act
Correct Answer: Public Health Service Act (PHS Act)
Q13. Post-marketing safety monitoring for biosimilars primarily involves:
- Preclinical animal studies
- Pharmacovigilance and adverse event reporting systems
- Eliminating all pharmacovigilance requirements for biosimilars
- Reporting only to the biosimilar manufacturer, not regulators
Correct Answer: Pharmacovigilance and adverse event reporting systems
Q14. Why are robust manufacturing controls critical for biologics and biosimilars?
- Manufacturing does not affect biologic quality
- Manufacturing variability can alter potency, safety, and immunogenicity
- They are only important for small-molecule drugs
- Only packaging controls matter for biologics
Correct Answer: Manufacturing variability can alter potency, safety, and immunogenicity
Q15. Which of the following is an example of analytical similarity assessment?
- Randomized blinded clinical outcomes study across multiple disease indications
- Comparative structural and functional characterization of protein primary, secondary, and higher-order structure
- Marketing surveys to physicians
- Patenting the manufacturing process
Correct Answer: Comparative structural and functional characterization of protein primary, secondary, and higher-order structure
Q16. The Purple Book differs from the FDA Orange Book in that the Purple Book:
- Lists approved small-molecule generics and therapeutic equivalence ratings
- Focuses on licensed biological products and biosimilarity/interchangeability
- Contains patent expiration dates for all drugs
- Is maintained by the European Medicines Agency
Correct Answer: Focuses on licensed biological products and biosimilarity/interchangeability
Q17. Which documentation supports extrapolation of indications for a biosimilar?
- Comprehensive scientific justification including mechanism of action and similarity data
- Only the cost-effectiveness analysis
- No documentation is required
- A consumer petition demonstrating market need
Correct Answer: Comprehensive scientific justification including mechanism of action and similarity data
Q18. In biosimilar naming and identification, a key goal is to:
- Make biosimilars indistinguishable from reference products in records
- Ensure unique identification for pharmacovigilance and traceability
- Remove all product identifiers to simplify labels
- Use brand names only without scientific names
Correct Answer: Ensure unique identification for pharmacovigilance and traceability
Q19. Clinical immunogenicity assessments for biosimilars primarily evaluate:
- Only long-term carcinogenic risk
- Risk of anti-drug antibody formation and potential clinical consequences
- Only manufacturing costs
- The nutritional content of parenteral formulations
Correct Answer: Risk of anti-drug antibody formation and potential clinical consequences
Q20. What role do analytical comparability data play in reducing the need for extensive clinical trials?
- They have no impact; full trials are always required
- High-quality analytical data can justify limited or focused clinical studies
- They replace all regulatory review steps
- They only support marketing claims, not approvals
Correct Answer: High-quality analytical data can justify limited or focused clinical studies
Q21. Which of the following is a likely reason a biosimilar application would include additional clinical data beyond analytical similarity?
- Clear analytical similarity with no residual uncertainty
- Residual uncertainties about clinical performance, safety, or immunogenicity
- To reduce submission costs
- Because clinical data are never required for biosimilars
Correct Answer: Residual uncertainties about clinical performance, safety, or immunogenicity
Q22. Which statement about the Purple Book update frequency is correct?
- The Purple Book is static and never updated after initial release
- The FDA updates Purple Book listings periodically as approvals occur or statuses change
- The Purple Book is updated hourly with clinical trial outcomes
- Only manufacturers can update Purple Book entries directly
Correct Answer: The FDA updates Purple Book listings periodically as approvals occur or statuses change
Q23. Which of the following best describes a “reference product exclusivity” impact on biosimilar approval?
- Exclusivity never affects biosimilar approval timelines
- Reference product exclusivity can delay biosimilar marketing even after approval
- Exclusivity accelerates biosimilar approvals automatically
- Exclusivity only applies to over-the-counter drugs
Correct Answer: Reference product exclusivity can delay biosimilar marketing even after approval
Q24. Who is primarily responsible for reporting adverse events for biologics in clinical practice?
- Only pharmaceutical sales representatives
- Healthcare professionals and manufacturers via pharmacovigilance systems
- Only the patients, never clinicians
- No one is required to report adverse events
Correct Answer: Healthcare professionals and manufacturers via pharmacovigilance systems
Q25. The “patent dance” in the US biosimilar framework refers to:
- A formal dance ceremony at FDA meetings
- A sequence of information exchanges and litigation-related procedures between reference sponsors and biosimilar applicants
- Marketing negotiations between pharmacies and manufacturers
- The WHO process for naming biologics
Correct Answer: A sequence of information exchanges and litigation-related procedures between reference sponsors and biosimilar applicants
Q26. Which of the following most accurately reflects why biosimilars may not be exact copies of reference biologics?
- Because manufacturers intentionally change active sequences to avoid patents
- Biologics are produced in living systems, so minor microheterogeneity may occur without clinical impact
- All biosimilars are chemically synthesized identically to references
- Biosimilars always have different indications by default
Correct Answer: Biologics are produced in living systems, so minor microheterogeneity may occur without clinical impact
Q27. Which element improves traceability of individual biologic products in clinical use?
- Recording only the drug class, not manufacturer or lot number
- Recording brand name, manufacturer, and lot/batch number in patient records
- Using only the nonproprietary name without batch information
- Using random codes unrelated to the product
Correct Answer: Recording brand name, manufacturer, and lot/batch number in patient records
Q28. In the context of biosimilars, what does “totality of evidence” mean?
- Deciding approval based only on sponsor reputation
- Assessing all analytical, nonclinical, and clinical data collectively to conclude biosimilarity
- Approving products solely on cost-effectiveness
- Reviewing only in vitro data for final decision
Correct Answer: Assessing all analytical, nonclinical, and clinical data collectively to conclude biosimilarity
Q29. Which stakeholder benefits directly from Purple Book clarity and accurate listings?
- Only pharmaceutical investors
- Healthcare providers, pharmacists, regulators, and patients using biologics
- Only marketing agencies
- Only patent attorneys
Correct Answer: Healthcare providers, pharmacists, regulators, and patients using biologics
Q30. For a B. Pharm student, why is understanding the Purple Book important in professional practice?
- It has no relevance to pharmacy practice
- It helps pharmacists counsel patients, ensure traceability, and understand regulatory status of biologics and biosimilars
- Only physicians need to know Purple Book contents
- It replaces the need to understand pharmacology of biologics
Correct Answer: It helps pharmacists counsel patients, ensure traceability, and understand regulatory status of biologics and biosimilars
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
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