Replies to post #79387 on Biotech Values

[DewDiligence]

MNTA: In the Citizen Petition SNY claims that it is unable to identify all of the structural features in enoxaparin that are responsible for mediating its effects through mechanisms other than anti-Xa and anti-IIa activity. So, says SNY - how can a biogeneric establishes equivalence to a drug that a large portion of it is un-characterized, without performing clinical trials? CHMP has already provided guidelines requiring at least one clinical trial. MNTA is confidant that its technology is good enough to fully characterize Lovenox and we can only bet on how the FDA will rule. In any case, SNY's use of the CP process to protect Lovenox reminds me of how it worked well for Wyeth with its CP for Premarin.

Your post suffers from a couple of misconceptions. First, just because SNY didn’t—or couldn’t—fully characterize Lovenox does not imply that MNTA cannot do it. Full characterization has never been required for FDA approval of a branded biologic, so there was no business impetus for SNY to even try.

Second, the EMEA/CHMP guidance documents on biosimilars are immaterial for the FDA. Europe does not have a Hatch-Waxman-like framework for generic drugs, and the EMEA has never been empowered to rule on the substitutability of one drug for another, whether they be biologics or small molecules.