Schachter, can you tell us the difference between a generic drug and a brand name?
The primary difference between a generic and a brand name drug is in the materials that are used to make it into a pill or a capsule. The active ingredient is identical. It’s how that active ingredient is packaged with the different kinds of materials that are used to make pills and capsules. It’s those differences that change how that active ingredient is applied into the body and results in its effectiveness. What is bioequivalence? When you swallow a pill, it needs to get absorbed through the stomach or the intestines. It then goes through the liver where it might be changed or broken down to some extent and eventually gets into the brain. But the amount that gets into the brain versus the amount that was swallowed. The extent of that difference might be different between a generic and a brand name medication. So we refer to the amount of medication that’s in the body versus from one preparation to another as the equivalent or the bioequivalence. And the FDA will allow that differen