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.