It seems to me that by selling Lovenox, MNTA can prove safety by examining actual outcomes of patients.
Apart from the possibility of a newly introduced manufacturing impurity—a risk that applies to branded Lovenox as much as the generic—nothing in NVS/MNTA’s generic could cause a safety problem. The reason is that the variation between an arbitrary lot of NVS/MNTA’s generic and an arbitrary lot of SNY’s branded Lovenox is as small as the variation between two arbitrary lots of branded Lovenox.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”