Isn't a concern of the FDA added risk of [FoB] immunogenicity?
Yes, to a degree, and the EMA can be expected to have a similar view. However, concern over immunogenicity pales in comparison to what Guido Rasi (the author of the passage you quoted) is implying about FoB efficacy. If the EMA requires all FoB’s to match the efficacy of biobetters as well as the first-generation biologics, it will clearly limit the number of approvable FoB applications.
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