>MNTA – they should have planned appropriately if they were messing around and cleaving sugars to try and produce a "biosuperior" or "bioequivalent" (which is what I think their platform entails if I am not mistaken)<
Just to be clear on the terminology: MNTA’s generic Lovenox is not a bio-anything. It is produced entirely through chemical synthesis.
I agree that every development must start with very careful planning and taking into account ALL variables and potential pitfalls. There is always the risk of immunogenicity and MNTA now have to come up with convincing data or they will have to generate it.
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