Ask the Pharmacist: July/August

Q: I can save money if I switch my medication to the generic,
however I am concerned it may not be as effective.
Are generics as good as the brand names?

A: A generic medicine works in the same way and provides the same clinical benefit as its brand-name version. This standard applies to all FDA-approved generic medicines. A generic medicine is the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, and quality, as well as in the way it should be taken and used.

FDA requires drug companies to demonstrate that the generic medicine can be effectively substituted and provide the same clinical benefit as the brand-name medicine that
it copies. The abbreviated new drug application (ANDA) submitted by drug companies must show the generic medicine is the same as the brand-name version in the following ways: The active ingredient in the generic medicine is the same as in the brand-name drug/innovator drug. The generic medicine has the same strength, use indications, form, and route of administration. The inactive ingredients of the generic medicine are acceptable. The generic medicine is manufactured under the same strict standards as the brand-name medicine. The container in which the medicine will be shipped and sold is appropriate, and the label is the same as the brand-name medicine’s label.

Generic medicines tend to cost less than their brand-name counterparts because they do not have to repeat animal and clinical studies that were required of the brand-name medicines to demonstrate safety and effectiveness. In addition, multiple applications for generic drugs are often approved to market a single product; this creates competition in the marketplace, typically resulting in lower prices. When multiple generic companies market a single approved product, market competition typically results in prices that are about 85% less than the brand-name product.