Of course SNY's claims in its petition that it couldn’t fully characterize Lovenox, does not imply that MNTA cannot do it. SNY's tactic like Wyeth's with its CP for Premarin, is putting a roadblock by showing the drug is poorly characterized and asking the FDA not to approve a generic version.
My other point is that the EMEA/CHMP guidelines talks about efficacy and safety. It states that since a clear correlation between surrogate PD parameters (antifactor Xa or IIa) and clinical outcome has not been established, a similar biological medicinal product containing LMWH should show therapeutic equivalent to a reference product approved in the EU by at least one clinical trial. Since there are no FDA guidelines on the requirements for generic approval of a complex heparin mixture, a future guidelines may resemble that of the EMEA/CHMP.
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