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Biosimilars Drug Review Reimbursement

Biosimilar Interchangeability May Be Losing Luster As Approval Goal

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Executive Summary

Pricing now may mean more to payers than whether the product is interchangeable.

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VA Changes Infliximab Biosimilars; Merck Formulary Win Could Drive Questions On Patient Switching

Move from one infliximab biosimilar to another could illuminate safety concerns surrounding non-medical switching – or at least Janssen hopes so; VA's national formulary moved from Remicade to Pfizer's Inflectra in 2017.

VA Changes Infliximab Biosimilars; Merck Formulary Win Could Drive Questions On Patient Switching

Move from one infliximab biosimilar to another could illuminate safety concerns surrounding non-medical switching – or at least Janssen hopes so; VA's national formulary moved from Remicade to Pfizer's Inflectra in 2017.

Interchangeable Biosimilars: FDA Clarifies US Reference Not Mandatory For Studies

Draft guidance strongly recommends against it, but US FDA's Leah Christl says agency is willing to talk about using foreign-licensed comparators.

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