Biosimilar Interchangeability: NOR-SWITCH-Type Study Not Enough For US FDA
Norwegian single-transition study would not satisfy agency's requirements for demonstrating interchangeability but could boost patient confidence in general concept of switching between reference product and biosimilar.
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FDA's user fee deal with sponsors sets target dates for documents on interchangeability, naming and labeling, but non-industry stakeholders urge agency to accelerate their release; guidance development efforts will get boost in BsUFA II with funding for new dedicated biosimilars unit starting in fiscal year 2018.
Biosimilar drug makers say that the NOR-SWITCH study on switching from Johnson & Johnson’s infliximab to the Celltrion product supports the concept of biosimilarity and proves that they are subject to the same regulatory standards as originators. Originators, meanwhile, want more evidence that switching works.