Biotech Values

[DewDiligence]

From the FDA’s own statement issued on the day it approved NVS/MNTA’s Lovenox (#msg-52582225):

The chemical reaction used to make enoxaparin sodium results in oligosaccharide fragments of distinctive sizes and sequences. It also modifies the chemical structure of sugar residues at both ends of the fragments. Such chemical modifications may affect the activity of this drug . If a manufacturer wants to make a generic enoxaparin sodium, it has to design a manufacturing process that is capable of reproducing these distinct features of the drug. Otherwise, a generic enoxaparin sodium might not behave in the same way in the body as the brand name counterpart, Lovenox.

Thus, demonstration of “sameness” for enoxaparin sodium requires “state-of-the-art” analytical methods to show that the structural features of oligosaccharides in the generic enoxaparin sodium are equivalent to those in Lovenox.

In other words, the FDA’s five criteria for “sameness” (equivalence of heparin source material and mode of depolymerization; equivalence of physiochemical properties; equivalence in disaccharide building blocks, fragment mapping, and sequence of oligosaccharide species; equivalence in biological and biochemical assays; and equivalence of in vivo pharmacodynamic profile) are merely a starting point—they are necessary but not sufficient to obtain FDA approval for a generic version of Lovenox.