Therapeutic Equivalence: Definition & Examples

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Instructor: Megan Gilbert

Megan has a master's degree in nursing and is a board certified Women's Health Nurse Practitioner. Her area of clinical focus is the impact of infectious disease on pregnancy. She has experience teaching college allied health classes. She is also a certified EMT and holds a certificate of added qualification in electronic fetal monitoring.

This lesson covers therapeutic equivalence, its definition, its implications, and examples. After you learn about what it is and some of its examples, you can test your knowledge with a quiz.

Therapeutic Equivalence: Definition

Your head is pounding and the nurse from your doctor's office has suggested you try a pain reliever, so you walk into the drug store. You make your way to the pain reliever aisle and you're confronted with row after row of options. Why are there so many brands? What's the difference between Tylenol® with an active ingredient of acetaminophen and the store brand acetaminophen?

According to the U.S. Food and Drug Administration (FDA), two medicines that have the same clinical effect and safety profile are said to have therapeutic equivalence. These two drugs, each from a different manufacturer, are known to have nearly identical properties and can be interchanged as needed.

These medicines are sometimes referred to as brand name medications and generic medications. According to the FDA, there should be no clinical difference between them, although patients often notice a difference in cost. This is what you're most likely to notice while you're in the pharmacy trying to find something to stop your headache.

The purpose of establishing if two medications are therapeutic equivalents is to allow the generic drug to go through a shorter, more cost-effective, approval process while still protecting public safety.

For a drug to be approved as a therapeutic equivalent it must:

  1. Be safe and effective
  2. Contain the same active ingredient as the original medication
  3. Utilize the same route of administration
  4. Be the same dosage
  5. Meet the same standards for strength, quality, purity, and identity
  6. Be bioequivalent (with bioequivalent meaning the body is able to process it in the same way that the original drug was processed)
  7. Be correctly labeled
  8. Be manufactured in accordance with the FDA's Current Good Manufacturing Practice regulations

Testing can be performed in vitro or in vivo. In vitro refers to when a test is done outside the living environment, sometimes referred to as test tube studies. In vivo refers to when a test is done on the entire living organism, such as when a drug trial is conducted on human participants.

Of note, these drugs do not need to have the same:

  1. Appearance (scoring, color, shape)
  2. Flavor
  3. Packaging
  4. Preservatives
  5. Release mechanisms
  6. Minor aspects of labeling

Sometimes, one of these will be of particular importance to a patient, and a physician may prescribe a brand-specific product.

The most important part of this is that the drugs have the same active ingredient. So, therefore, both Tylenol® and the store brand drug must contain acetaminophen, even though they will be produced by different companies. While acetaminophen and ibuprofen can both be used to treat your headache, because they are different medications they would never be considered therapeutic equivalents.

Therapeutic Equivalence: Examples

The FDA keeps a list (known as the Orange Book) of every approved therapeutic equivalent.

One prescription example would be combined oral contraception, also known as the birth control pill. While there are many formulations of oral contraception, the combination of desogestrel 0.15mg and ethinyl estradiol 0.03mg is available under the following names from different companies:

  • Desogen
  • Emoquette
  • Enskyce
  • Isibloom
  • Reclipsen
  • Apri
  • Ortho-Cept
  • Solia
  • Cyred
  • Juleber

These various brands may come in different colors and packaging. But the expectation is that they can be substituted for one another with little difficulty.

Another example is the oral diazepam tablets (brand name Valium), often used for muscle spasms and anxiety. The tablets are available from the following companies:

  • Barr: 2mg, 10mg
  • Ivax Sub Teva Pharmaceuticals: 2mg, 5mg, 10mg
  • Mayne Pharmaceuticals: 2mg, 5mg, 10mg
  • Mylan: 2mg, 5mg, 10mg
  • Vintage Pharmaceuticals: 2mg, 5mg, 10mg
  • Roche Pharmaceuticals: 2mg, 5mg, 10mg (the original holders of the patent)
  • Dava Pharmaceuticals Inc: 2mg, 5mg

As you can notice, not every company produces every approved dosage. The only requirement for therapeutic equivalence is that the dosages are the same as the original approved medication.

Several examples apply to treating your pounding headache. If you wanted an over-the-counter medication (OTC), meaning an option available without prescription, here are a few choices:

  1. The active ingredient in Tylenol (acetaminophen) is available from various brands.
  2. The active ingredient in Motrin and Advil (ibuprofen) is available from various makers.
  3. The active ingredient in Excedrin and Bayer's (aspirin) is available from various makers.

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