I would still think they would have had to sign off the mfg. plant and the consistency of the process. But I am probably wrong because there is no consistency of process for Lovenox, for example.
I can tell you though, that if I was a doc and MNTA Copax got approved, I would go for the brand just to be sure. Too many potential ifs. Of course, insurers would normally prefer generics.
Of course the new healthcare bill may change that - with limits on how much money can be spent on non-health spending related items (profits, exec salaries?, interest expense?, etc.), it may be to the insurance company benefits to allow massive inflation of costs to get their "rate base" up. The law of unintended consequences.
Jon
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