US FoB programs have been disappointments, by and large. However, the impediment to commercial success has not been FDA approval, but rather the extensiveness of blocking IP (e.g. ABBV's Humira) and PBM contracting that seeks to lock out an FoB (e.g. PFE-JNJ lawsuit on Remicade).
In the EU and other parts of the world, more FoBs have launched and garnered respectable market share.
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