The Development and Approval of Inflectra, a biosimilar to Remicade: Case Presentation

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* 1. First Name

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* 2. Last Name

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* 3. Email address

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* 4. According to the FDA, biosimilar development differs from standalone development because:

A. Standalone development requires analyzation of the structure and function of the product rather than clinical data.

B. Biosimilar development requires analyzation of the structure and function of the product rather than clinical data.

C. Standalone development addresses safety, efficacy, and biosimilarity.

D. Biosimilar development does not require animal studies to demonstrate the clinical efficacy of the biosimilar as compared to the reference product.

E. None of the above

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* 5. Extrapolation is based on:

A. Totality-of-the-evidence.

B. FDA’s previous finding of safety and efficacy for other approved indications of the reference product, including IBD indications.

C. Adequate justification of scientific factors to support extrapolation.

D. All the above

E. None of the above

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* 6. What differences between CT-P13 and US-licensed Remicade should gastroenterologists take into consideration?

A. CT-P13 has a different strength, dosage form and route of administration than US-licensed Remicade.

B. CT-P13 is approved for Adult Crohn’s Disease and Adult Ulcerative Colitis only.

C. CT-P13 is approved for Pediatric Crohn’s Disease only.

D. CT-P13 is approved for Adult Ulcerative Colitis only

E. There are no differences between CT-P13 and US-licensed Remicade in strength, dosage form, route of administration, and approved indications.