Pretest - AGA Expert Exchange: Biosimilars in GI

Please complete these questions prior to participating in the live Twitter chat.

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* 1. Name

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* 2. Degree

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* 3. Which of the following is TRUE about the FDA biosimilar development process?

Phase III trials comparing reference vs biosimilar efficacy are necessary for each FDA approved disease state.

The naming process for biosimilars includes a four letter suffix consisting of random letters assigned to identify the different biosimilars.

Pharmacovigilance includes reporting adverse effects to the biosimilars during the clinical trial period only.

Biosimilars are exact copies of the reference product in terms of manufacturing process, efficacy and safety.

Biosimilars can lead to substantial cost savings at the patient level.

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* 4. Which of the following statement is NOT true?

Randomized controlled trials in patients with IBD have demonstrated similar rates of clinical efficacy between reference infliximab and biosimilar infliximab for induction of remission.

Randomized controlled trials in patients with IBD have demonstrated that switching from infliximab reference to biosimilar infliximab is safe and not associated wit loss of response to treatment.

Randomized controlled trials in patients with IBD have demonstrated similar rates of clinical efficacy between reference adalimumab and biosimilar adalimumab for induction of remission.

Randomized controlled trials in patients with IBD have shown that multiple switches between reference adalimumab and biosimilar adalimumab is safe and not associated with loss of response to treatment.

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* 5. The FDA has approved which of the biosimilars as the first interchangeable biosimilar?

Infliximab-dyyb (Inflectra)

Infliximab-abda (Renflexis)

Adalimumab-adbm (Cyltezo)

Adalimumab-atto (Amjevita)

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* 6. When planning a nonmedical switch from a reference biologic to biosimilar in your practice, all of the following are important EXCEPT:

Provide links to or written educational materials to patients prior to the switch.

Educate staff and providers about concept of biosimilars, overview of efficacy and safety, and rationale for switch.

Notify patients of intention to switch 2 weeks prior to infusion/injection.

Allow patients opportunity to decline switch if not mandated by the payer.

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* 7. A 23-year-old man with extensive ulcerative colitis has been in a deep remission with sustained histologic remission on infliximab 5mg/kg every 8 weeks. He denies any attenuation or infusion reactions associated with infliximab. He recently changed jobs and his new insurance is requiring that he switch to infliximab-dyyb. Which of the following is correct?

Azathioprine should be added to prevent immunogenicity due to a change in anti-TNF.

Anti-drug antibodies should be checked after 3 infusions of infliximab-dyyb.

There should be no change in his monitoring strategy with this switch to biosimilar.

Fecal calprotectin and C-reactive protein should be checked at week 12 after switching.

For therapeutic drug monitoring, his provider should use a different assay to check infliximab-dyyb levels.