Biosimilar Cost-Savings Needed To Balance Extrapolation Risk, Advisors Tell FDA
Inflectra should be priced considerably lower than Remicade given that approval for some indications would be based on extrapolation, advisory committee members said; Celltrion exec suggests price could approximate the 30% discount seen in Europe.
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Office of New Drugs Director Peter Stein tells the Pink Sheet that last phase of massive reorg was complicated by pandemic restrictions that forced review staff to work remotely, but the structural overhaul resulted in smaller, more nimble review groups and the breaking down of silos that ultimately helped the agency’s response to the public health crisis.
Division of Mitigation Assessment and Medication Error Surveillance will be established within the Office of Surveillance and Epidemiology, a change aimed at strengthening postmarketing oversight of opioids and other drugs; new Office of Safety and Clinical Evaluation will be created in Office of Generic Drugs, where Orange Book staff also will get their own division.