Replies to post #86130 on Biotech Values

[iwfal]

Biologics, definition of -

Copaxone was approved as an NDA not a BLA since it is a mixture of synthetic polypeptides. But given its complexity I believe the FDA will treat it as a biologic.

The implication of this is that the FDA makes a judgement and doesn't just follow the rote statutory definitions - which are clearly not perfectly aligned with chemical reality. If that is the case then why wouldn't that also be true of how they adjudge the Lovenox ANDAs? And when (if ever) would it be clear what their ruling was?