Just How Close Is That "Therapeutically Equivalent" Generic Drug?

Generic medications offer a lower cost option that can be expected to deliver the same effectiveness and safety as the brand. To earn this designation, a generic medication must prove to the U.S. Food and Drug Administration (FDA) that it is therapeutically equivalent to the brand-name counterpart. The FDA ensures that the generic(2):

- contains the same active ingredient(s)

- has the same dosage form and route of administration
is identical in strength or concentration

- meets standards of strength, quality, purity and identity

- is bioequivalent: rate and extent of absorption of the generic is not significantly different from the brand

Bioequivalence is key to a generic medication being considered therapeutically equivalent. Measuring a drug’s rate and extent of absorption in humans can result in a range of values. Despite this fact, the FDA requires 90% of the values measured for a generic product to fall within a prespecified range with respect to the FDA-approved brand(3). The actual statistical ranges allowed for the rate and extent of absorption of a generic drug can be found on the FDA Web site (www.fda.gov/cder/ogd).

Generic medications that have proven to be therapeutically equivalent are given an “A” rating by the FDA(1). For more information, please go to http://www.fda.gov/cder/orange/default.htm.

Generic medications will continue to provide an affordable option to patients needing prescription medications. You can ensure they will receive a safe and effective generic medication by writing the prescription for the generic or indicating that substitution is allowed. Only generics that are approved as A-rated therapeutic equivalents to the brand-name counterpart will be substituted for the brand when you allow generic substitution.

Please visit us today at www.caremark.com/hp to see an extensive list of generics available by brand name or drug class and to learn more about our Count on Generics® program.

REFERENCES

1. U.S. Food and Drug Administration. FDA-Approved Bargain Drugs: Generic Products Must Meet High Standards. Available at: www.fda.gov/opacom/factsheets/justthefacts/18generic.html.
Accessed October 22, 2007.

2. U.S. Food and Drug Administration. Approved Drug Products with Therapeutic Equivalence Evaluations. 27th ed. Rockville, MD: US Department of Health and Human Services; updated January 30, 2007. Available at http://www.fda.gov/cder/orange/obannual.pdf. Accessed October 30, 2007.

3. Benet LZ. Understanding Bioequivalence Testing. Transplantation Proceedings. 1999;31(suppl 3a):7s-9s.

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