Biotech Values

[DewDiligence]

When you say that "NVS/MNTA's is identical to branded Lovenox," you mean identical for commercial purposes, not in a technical/scientific sense, right? The drugs don't have to be perfectly identical (just "bioequivalent"), right?

With a product derived from a biologic source such as bulk heparin, no two lots are ever going to be identical in the strict scientific sense of having the exact atoms in the exact configurations. However, an arbitrary lot of NVS/MNTA’s generic Lovenox is as close to an arbitrary lot of branded Lovenox as one lot of branded Lovenox is to another lot of branded Lovenox, which is good enough for the FDA.

I can’t answer your questions about the detailed regulatory requirements in India for a branded generic like the Copaxone knockoff from Natco. It’s clear that the scientific hurdle for such a product is considerably lower than the hurdle for a substitutable generic approved by the FDA.