Biotech Values

[biomaven0]

In fact, the active ingredient “sameness” criteria outlined by FDA to approve a generic version of Lovenox® without clinical trials reinforce our position that the only way to ensure a purported generic Copaxone® would have no significant clinical consequences would be to conduct pre-clinical and full-scale, placebo-controlled clinical trials with measured clinical endpoints in MS patients to establish safety, efficacy and immunogenicity in a real patient population [ie since lovenox didn't require clinical trials, then logically that means Copaxone will require them. lol]."

Actually the quote is not crazy at all, although the phrasing could certainly be improved. If you look at the 5 "sameness" criteria for Lovenox, a key one is a preclinical measure of efficacy. That test is missing in the Copaxone case, and that fact certainly makes the approval hurdle higher from the FDA's perspective.

Peter