Approvals

[COLOR=black]One consequence of a drug being a molecule is generic versions can exist. Generics are approved to treat conditions only because they are equivalent to the original drug. Simvastatin by generic manufacturers is approved to reduce cholesterol only because Zocor (the original simvastatin) is. However, that does not mean that any statin-type molecule is approved for cholesterol reduction: each of the branded statins on the market has approval because their respective manufacturers obtained it. [/COLOR][COLOR=black][/COLOR]
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[COLOR=black]Because IVIg is a blood product, there is no specific molecule (or even set of molecules) to approve, and so there is no way to make a generic IVIg. And in the same way that the different statins had to obtain approval to treat the same condition, so also the different IVIg’s must obtain approval to treat the same condition.[/COLOR][COLOR=black][/COLOR]
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[COLOR=black]I did survey of the IVIg’s offered in the USA. Based on that survey, all of the IVIg’s are indicated for treatment of primary immunodeficiency disorders. Only Gammunex-C is indicated for the treatment of CIDP. That means if your insurance company wants to be picky, they could restrict you to Gammunex-C only.[/COLOR][COLOR=black][/COLOR]
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[COLOR=black]~MarkEns[/COLOR]