Biotech Values

[DewDiligence]

[OT/follow-up]—Another instance where small-molecule generic drugs were found to be substantially different from the brand (and likely from each other):

http://www.nytimes.com/2015/06/17/business/generic-ritalin-drug-not-equivalent-to-the-brand-is-in-use-anyway.html

There’s a serious loophole in the FDA guidelines for generic drugs: although a given generic drug must have 80-125% of the bioavailability of the reference branded product, the difference in bioavailability between one generic and another generic for the same brand could be as much as 125/80, a whopping 56%. Evidently, the FDA failed to entertain the notion of switching between one generic and another when they formulated the guidelines for bioavailability of small-molecule generics.