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Re: mouton29 post# 108347

Sunday, 11/07/2010 4:38:58 PM

Sunday, November 07, 2010 4:38:58 PM

Post# of 257581

…your logic seemed to be chiefly based on the fact that the EMA guidelines require a clinical trial.

A larger drawback is that an ex-US Lovenox biosimilar would not be automatically substitutable for branded Lovenox and hence would need to be actively marketed.

Don't you think CW Is suggesting that it might be possible, given the US approval, to persuade the EMA to change those guidelines?

Yes, Wheeler was suggesting that, but I don’t think it’s a likely outcome.

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