Two Months To Add Two Words – Biosimilar Supplement Review Times May Be Hindering Uptake
Biosimilar supplement approvals by the US FDA take on average about five months as sponsors request easier and quicker ways to update labels.
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Following months of negotiations with industry and stakeholders, the FDA has released the commitment letter for the third iteration of its five-year Biosimilar User Fee Amendments program, marking another step ahead of its reauthorization.
Six supplement categories based on submission content will be created with review goals between three and 10 months.
New guidance from UK's MHRA saying comparative clinical efficacy studies typically will not be needed is a start, but other regulators may need a few years before adopting similar rules.