MNTA – Although enoxaparin (Lovenox) is not a biologic, my sense is that the FDA is stalling until Congress passes enabling legislation for generic biologics. If this is correct, it means a lengthy delay for MNTA because the 2007 Congressional season is almost over and there is little if any hope for the House to pass such a bill in 2007. (The Senate has already passed such a bill.)
In other words, I’m speculating that the immunogenicity issue may be a red herring.
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