Biotech Values

[iwfal]

You’re still not making any sense

I would suggest that genisi's argument is about bureaucratic behavior. Copaxone is "officially" (i.e. per FDA bureaucratic definitions) not a biologic - so they had to accept the ANDA. BUT scientifically Copaxone is a lot more like a biologic than like a small molecule - so the internal approval pathways for an ANDA make no sense. Sooooo, what does a bureaucracy do in that circumstance... wait, wait, wait (in the hopes, in this case, that the overall bio-equivalence changes will clarify what to do).

I think that genisi then further believes that the FDA will, if forced to make a decision, decide efficacy trials are necessary. (I disagree with this - at least not without a strong forcing function. Because bureaucracies, unlike courts or congress, don't like to go where they have no cover. And requiring an efficacy trial for an ANDA is definitely very very new ground.)