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Tatsumaki

03/11/23 2:03 PM

#405560 RE: CaptBeer #405556

What you think looks BE doesn't matter. It's a regulatory definition and that's what the industry uses. Multiple generics have approval and are actively selling. Too late to close the barn doors.

Even the big drug companies don't bother fighting generics too hard over this stuff. Cause they ususally have a pipeline of improved drugs to go to market and just displace generics that way. Trying to split hairs over BE with a generic isnt going to do anything for Amarin but waste money cause they're going to lose. The only way to cut into a generic is to prove a safety issue.

hypo

03/11/23 2:53 PM

#405564 RE: CaptBeer #405556

Capt, Without a Reduce-It type study nothing is proven except it is crap.
Cheers

marjac

03/11/23 4:01 PM

#405568 RE: CaptBeer #405556

Captain,

What is the source for these pie charts showing that Hikma's GV is 31% watered down in terms of EPA purity? Is this an indisputable documented fact? Is there similar available data for the other generics?

If this is indeed true, then Hikma as well as the insurance companies might be committing an unconscionable commercial practice under applicable consumer fraud laws. If the data is concrete, then a massive Class Action is potentially viable, as I have discussed here in the past.

ziploc_1

03/11/23 4:22 PM

#405574 RE: CaptBeer #405556

The EPA is the active ingredient in Vascepa...The effect of the EPA within the gV capsule is weakened by excess oxidation due to its inferior capsule...but it's effect is, in addition, weakened by the fact that than it has ONE THIRD LESS EPA than the Vascepa 1000 mgm capsule (i.e.due to the need for the generic companies to allow room for the XS fillers in their inferior gV capsule...in a faiIing attempt to curb EPA oxidization in their product)...Is gV then really bioequivalent to Vascepa?...I don't think so.