An Independent Clinical Trial Center
GENERIC AND/OR BIOEQUIVALENT DRUG INFORMATION
What are generic drugs?
A generic drug an identical or bioequivalent of a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price.
Creating a drug costs lots of money. Since generic bioequivalent drug makers do not develop a drug from scratch, the costs to bring the drug to market are less; therefore, generic drugs are usually less expensive than brand-name drugs. But, generic drug makers must show that their product performs in the same way as the brand-name drug.According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generics.
Not every brand-name drug has a generic or bioequivalent drug. Why?
When new drugs are first made they have drug patents. Most drug patents are protected for 20 years. The patent, which protects the company that made the drug first, doesn't allow anyone else to make and sell the drug. Once that patent expires, other drug companies can start selling their own version of the drug. But, first, they must test the drug and the FDA must approve it.
Northern California Research does many new generic/bioequivalent studies for manufacturers seeking FDA approval of their own remake of a brand and original version drug. You can be a part of this process. Call or contact us to learn more about how easy it is to participate!
Are generic drugs as effective as brand-name drugs?
Yes. FDA requires generic drugs have the same high quality, strength, purity and stability as brand-name drugs. A generic drug is the same as a brand-name drug in dosage, safety, strength, quality, the way it works, the way it is taken and the way it should be used.
How are generic/bioequivalent drugs approved?
These tests usually involve a few hundred to a few thousand patients. Since the safety and efficacy of the brand-name product has already been well established in clinical testing and frequently many years of patient use, it is scientifically unnecessary, and would be unethical, to require that such extensive testing be repeated in human subjects for each generic drug that a firm wishes to market. The generic/bioequivalent applicants must scientifically demonstrate that their product performs in the same manner as the pioneer drug.
One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream and its concentration in the bloodstream in clinical trial volunteers. This gives them the rate and extent of absorption-or bioavailability-of the generic drug, which they then compare to that of the pioneer drug. The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the pioneer drug.
Using bioequivalence as the basis for approving generic copies of drug products was established by the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. Brand-name drugs are subject to the same bioequivalency tests as generics when their manufacturers reformulate them.
Health professionals and consumers can be assured that FDA approved generic drugs have met the same rigid standards as the innovator drug. To gain FDA approval, a generic drug must:
-contain the same active ingredients as the innovator drug(inactive ingredients may vary)
-be identical in strength, dosage form, and route of administration
-have the same use indications
-meet the same batch requirements for identity, strength, purity, and quality
-be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products
Many of our current studies are for generic and/or bioequivalent medication approvals. If you would like to participate, please call our office and ask about these great studies.