WHAT IS A "GENERIC" DRUG?
Generic drugs have the same medicinal ingredients as the original brand name drugs, but cheaper in price. They undergo for testing to ensure that they are equal to their brand counterparts such as:
- Active Ingredient (ex. Pravastatin is the active ingredient in brand name Pravachol)
- Dosage (ex. 10mg of the active ingredient)
- Safety (ex. same or similar side effects, drug interactions)
- Strength
- Quality
- Performance (ex. 10mg of a generic can be substituted for 10mg of the brand and have the same therapeutic result)
- Intended use (ex. both generic and brand would be prescribed for the same conditions)
WHAT DIFFERENCES ARE THERE BETWEEN GENERIC AND BRAND?
While generics and brand equivalent drugs contain the same active ingredients, they may be different in the following ways:
- Color
- Shape
- Size
- Cost
- Appearance (ex. the scoring or markings)
The color, shape, and size of the medication come from the fillers that are added to the active ingredients to make the drug. These fillers that are added to the drug have no medical use and are regulated so they do not change the effectiveness of the final product. A generic drug must contain the same active ingredients and must be equivalent in strength and dosage to the original brand name equivalent.
WHY DO GENERICS COST LESS THAN THE BRAND NAME?
When a new drug is invented the company that discovered it has a patent on it that gives them the exclusive production rights for this medication. Once the patent expires other companies can bring the product to market under their own name. This patent prevents other companies from copying the drug during that time so they can earn back their research and development costs through being exclusive supplier of the product. These versions generally are offered at much lower prices because the companies do not have the same development costs as the original company who developed the medication. The two products are therapeutically equivalent even if they might look different or be called different.
HOW ARE GENERIC DRUGS TESTED TO ENSURE QUALITY AND EFFICACY?
The two most accepted methods to prove the safety of a generic version of a drug are either to:
- repeat most of chemistry, animal and human studies originally done or
- to show that the drug performs comparably with the original brand name drug
This second option is called a "comparative bioavailability" study. During this type of study, volunteers are given the original drug, and then separately later the generic drug. The rates at which the drug is delivered to the patient (into their blood stream or absorbed) are measured to ensure they are the same. Because the same active ingredient is used the major concern is just that it delivers the common chemicals at the same rate so that they have the same effect.
