Sandoz’s Biosimilar Filgrastim Sails Through FDA Panel
This article was originally published in The Pink Sheet Daily
Extensive European experience helps reassure Oncologic Drugs Advisory Committee about safety and similarity to Amgen’s Neupogen.
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Agenda for Thursday’s meeting on coronavirus vaccine development and approval includes lots of background, which may help public confidence, but not necessarily FDA assessors as they weigh the tough decisions ahead of them.
Advisory committee says planned waivers for molecularly targeted studies should take into account comparative adult efficacy and toxicity data for multiple drugs in the same class, as well as differences in product attributes, such as route of administration and dosing schedule; unmet clinical need should have less influence on decision to grant waivers, panelists said.
The use of various acronyms – including RRA, RIE and RRR – to describe remote assessments of sites and study data has been confusing and makes it sound as though people are speaking ‘like a pirate,’ Office of Study Integrity and Surveillance director Sean Kassim says.