MINNEAPOLIS (WCCO) — The maker of EpiPen announced Monday it would make a generic version of the drug for about half the price. The company recently came under fire for hiking the price of the allergy medication 400 percent.
Generic drugs can be introduced after the patent or exclusivity for the brand name runs out. So, what’s the difference between brand-name and generic drugs? Good Question.
Generic drugs must be approved by the Food and Drug Administration. It sets high standards in regards to strength, quality, purity and potency where only very small variations are allowed. The generic manufacturer must also be able to prove it can make the drug correctly and consistently.
Generics must have the same active ingredient as the brand-name. It must also have the same strength, dosage form and route of administration (ex., tablet, capsule, injectable). The manufacturer must also prove the generic is the bioequivalent of the brand-name drug. That means when a person’s blood is tested after receiving either drug, the same levels of medicine must be found.
The inactive ingredients, like the chemicals that bind the drug or give it color, can be different. The generic version is also required to look different than the brand-name.
Several studies have shown generic drugs work just as well as their brand-name equivalents. According to Jason Varin, an assistant professor at the University of Minnesota’s College of Pharmacy, brand-names are no better than generics. In most cases, Varin says people can’t tell the difference.
“There’s always a caveat to that,” Varin says. “In some instances, you may find a generic that works better than a name brand. Some instances, you may find a name brand that works better than a generic in a particular individual.”