Replies to post #86133 on Biotech Values

[genisi]

FDA makes a judgment and doesn't just follow the rote statutory definitions - which are clearly not perfectly aligned with chemical reality.

Exactly why the Lovenox ANDAs are still pending with the FDA after so many years. The FDA is perfectly capable scientifically to deal with the issue of biogenerics and biosimilars but I will not be surprised if it delays the decision until a generic biologics legislation set to emerge.

[DewDiligence]

…the rote statutory definitions - which are clearly not perfectly aligned with chemical reality.

The FDA’s dividing line between the NDA pathway and the BLA pathway, although arbitrary, is applied consistently. Peptides, sugars, and non-glycosylated proteins are reviewed as NDA’s, while glycoproteins are reviewed as BLA’s.