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Meowza

07/27/22 2:21 PM

#384451 RE: Gusman #384447

If it's bioequivalent it's bioequivalent. Otherwise you're welcome to try a new CVOT.
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Pharmacydude

07/27/22 3:27 PM

#384461 RE: Gusman #384447

Gusman
Neither the pharmacy nor the insurance company is violating the patents if they offer the Pt Vascepa-R-IT at $300 and gV for $10. It is the Pt (in the eyes of the law) who is violating the patent and choosing gV because it costs them less. HealthNet’s entire defence is that it is not considered inducement if all you do is make product A less expensive than product B. It’s the person who buys the product who is responsible.
The only solution is exclusivity contracts like MK is negotiating now.
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CaptBeer

07/27/22 3:55 PM

#384465 RE: Gusman #384447

The determination of substitutability of a generic for its Reference Listed Drug (RLD) is contained in the FDA's Orange Book. Every generic drug has an RLD. The FDA assigns a TE Code (Therapeutic Equivalence) of "AB" if they are therapeutically equivalent. PharamacyDude can correct me if I'm wrong, but this is where pharmacies look to see if they can substitute. It doesn't matter what name brand the RLD holder has on the drug. It's the active ingredient that is evaluated in the Orange Book.