It’s not my area of expertise, so I can’t give you a precise definition of “bioequivalence,” but my understanding is that it means roughly getting the same drug at the same level in the relevant area of the body as the brand drug. So for Vascepa it would probably mean getting the same blood level of EPA as Vascepa achieves for more or less the same time period. I also understand that there is leeway about how bioequivalence is accomplished. Certainly there is no need for the same formulation as the brand. If you take a drug that has gone generic and look at the products from several generic suppliers, you will see that, while the active ingredient is exactly the same, the other ingredients can vary widely. If generics can demonstrate bioequivalence, they don’t need to reproduce the REDUCE-IT results. The whole point of the ANDA process is to avoid making them do that. It is assumed that if the same active ingredient gets to the right place in the body in the right amount it will have the same therapeutic effect that the brand drug demonstrated when the brand company ran its clinical trials.
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