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 rull. 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.
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