An innovator drug is the first drugs created containing its specific active ingredient to receive approval for use. It is usually the product for which efficacy, safety and quality have been fully established. When a new drug is first made, drug patent usually will be acquired by the founding company. Most drug patents are protected up to 20 years. During the patent period, other companies cannot make or sell the same drug until the patent expires.
A generic drug is made of the same active ingredient as its innovator drug. An active ingredient is the chemical contained inside a drug that makes it work. In other words, the pharmacological effect of a generic drug is exactly the same as those of its innovator counterpart. Other companies can manufactures the generic drugs when patent expires.
Are innovator drugs and generic drugs similar?
Yes, There are similarities between generic and innovator drug, such as:
- Active ingredient
- Strength (dose)
- Therapeutic effect
- Side effects
- How to take
Examples Of Innovator And Generic Drugs
Are generic drugs as safe as the innovator drugs ?
Drug Control Authority (DCA) in Malaysia, imposes stringent evaluation for all products include generic drugs to be listed in Malaysia to ensure quality, safety and effectiveness. Generic Drugs are required to undergo bioequivalence (BE) studies to ensure the therapeutic effect of generic drugs are equivalent (can be interchanged ) with the innovator drug before drugs are allowed to be marketed in Malaysia.. Therefore, registered generic drugs are as safe and effective as innovator drugs.
Myths of Generic Drugs
Some myths that are often associated with generic drugs:
- Generic drugs are not as safe as innovators.
- Generics drugs are not as effectives as innovator
- Generics drugs take longer time to act in the body.
Generic drugs use the same active ingredients as innovator drugs and work the same way. So they have the same risks and benefits as the innovator drugs.
Generic drugs may look different because of certain inactive ingredients, such as colors and flavorings agents, may be different. These ingredients do not affect the safety, effectiveness or performance of the generic drug.
So, there’s no truth in the myths that generic drugs are inferior in quality as compared to innovator drugs.
Generic Drug Issues
Innovator drugs are more expensive because the company who first manufactures the drug spends large amount of money in research to develop the new drug which includes clinical trials, marketing and promotion of the drugs.
Generics drugs are cheaper as their manufactures are not required to demonstrate their efficacy and safety through clinical trials as these have also been established by the innovators.
However, generics drugs still needs to conform to same standard of quality, safety and efficacy required of the innovators. In addition, when the patent of a drug expired, there will be more company produce generic drugs which create competition and may reduce the cost of a drug.