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Biosimilars

Drug Profile
Infliximab
Drug Profile
Adalimumab Injection, Solution 40 mg/0.8 mL
Drug Profile
Adalimumab-aacf 40mg SC
Drug Profile
Adalimumab-aaty 40mg/80mg SC
Drug Profile
Adalimumab-adaz 10mg/20mg/40mg SC
Drug Profile
Adalimumab-adbm 10mg/20mg/40mg SC
Drug Profile
Adalimumab-atto 40mg/80mg SC
Drug Profile
Adalimumab-bwwd 40mg SC
Drug Profile
Adalimumab-fkjp 20mg/40mg SC
Drug Profile
Adalimumab-afzb 10mg/20mg/40mg
Drug Profile
Adalimumab-aqvh 40mg SC
Drug Profile
Ustekinumab
Drug Profile
Vedolizumab 108mg injection/300mg infusion
Michael Chiorean, MD Swedish Medical Center

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Ask the Expert

Recent Questions

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1. What is the primary factor that differentiates an originator biologic from a biosimilar?

Select only 1 answer.

  1. A. The molecular structure
  2. B. The cost of development
  3. C. The route of administration
  4. D. The active ingredient

2. Which statement is true about the extrapolation process for biosimilars?

Select only 1 answer.

  1. A. Extrapolation is not allowed by regulatory agencies.
  2. B. Extrapolation allows biosimilars to be used for all indications of the originator biologic if equivalence is shown in one indication.
  3. C. Extrapolation requires new clinical trials for each indication.
  4. D. Extrapolation is only applicable for non-clinical uses.

3. Which of the following is required for a biosimilar to gain the FDA designation of interchangeability?

Select only 1 answer.

  1. A. Evidence from at least one clinical trial
  2. B. Demonstration of no significant differences in PK/PD in at least three switch studies
  3. C. Approval in one indication
  4. D. Lower manufacturing costs

4. Which biosimilar has been approved by the FDA as interchangeable with its originator as of 2024?

Select only 1 answer.

  1. A. Infliximab
  2. B. Adalimumab
  3. C. Ustekinumab
  4. D. Vedolizumab

5. In the NOR-SWITCH study, which patient group showed a borderline significant increase in disease worsening when switched from an originator to a biosimilar?

Select only 1 answer.

  1. A. Patients with Ulcerative Colitis
  2. B. Patients with Crohn’s Disease
  3. C. Patients with Rheumatoid Arthritis
  4. D. Patients with Psoriatic Arthritis

6. Which of the following is a concern when switching patients from an originator biologic to a biosimilar?

Select only 1 answer.

  1. A. Increase in cost
  2. B. Nocebo effect
  3. C. Change in administration route
  4. D. Loss of patient consent

7. Which characteristic is essential for a biosimilar to be considered highly similar to its reference product according to FDA guidelines?

Select only 1 answer.

  1. A. Identical manufacturing process
  2. B. Exact same chemical structure
  3. C. No clinically meaningful differences
  4. D. Same patent expiration date

8. What was a key finding in the VOLTAIRE-CD study regarding the switching of adalimumab to its biosimilar?

Select only 1 answer.

  1. A. Increased adverse events in the biosimilar group
  2. B. Inferior clinical response in the biosimilar group
  3. C. No significant difference in safety and efficacy
  4. D. Requirement of additional immunosuppressants

9. Which of the following represents a major advantage of biosimilars over originator biologics?

Select only 1 answer.

  1. A. Reduced efficacy
  2. B. Increased immunogenicity
  3. C. Lower cost
  4. D. Fewer indications

10. Which biosimilar has been shown to have a higher dropout rate when the switching was open-label rather than blinded?

Select only 1 answer.

  1. A. Infliximab
  2. B. Adalimumab
  3. C. Ustekinumab
  4. D. Vedolizumab

11. How do manufacturing changes affect biosimilars compared to originator biologics?

Select only 1 answer.

  1. A. Biosimilars are less affected due to simpler manufacturing processes.
  2. B. Both are equally affected by changes in manufacturing.
  3. C. Biosimilars are more robust and less prone to drift.
  4. D. Originator biologics have already undergone multiple changes making them like biosimilars.

12. In which scenario would a patient likely require closer monitoring when switched to a biosimilar?

Select only 1 answer.

  1. A. Switching during the maintenance phase
  2. B. Switching during a clinical remission
  3. C. Switching at the initiation of therapy
  4. D. Switching after a failed response to the originator

13. Which outcome is most likely after a double-switch from an originator biologic to one biosimilar and then to another biosimilar?

Select only 1 answer.

  1. A. Improved clinical response
  2. B. Increased risk of treatment failure
  3. C. Reduced adverse events
  4. D. Higher overall drug cost

14. Which of the following is not a required component for biosimilar approval by the FDA?

Select only 1 answer.

  1. A. Analytical similarity
  2. B. Clinical efficacy trials for all indications
  3. C. Pharmacokinetic studies
  4. D. Immunogenicity assessment