Generic Drugs: Questions And Answers

A generic drug is a drug created to be the same as a brand-name drug already on the market in terms of dosage, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help demonstrate bioequivalence, which means that a generic drug works in the same way and provides the same clinical benefit as its brand-name version. In other words, you can substitute a generic drug for your brand name drug.

Do generic drugs work the same as brand name drugs?

Yes. Any generic drug created with a model brand drug must have the same effects on the body as that brand name drug. This standard applies to all generic drugs. A generic drug is the same as a brand name drug in its dosage, safety, effectiveness, potency, stability and quality, as well as the way it is taken and the way it should be used. Generic drugs use the same active ingredients as brand name drugs and work in the same way, so they have the same risks and benefits as brand name drugs.

The Food and Drug Administration’s (FDA) Generic Drug Program implements rigorous testing to make sure generic drugs meet these standards, in addition to inspecting 3,500 manufacturing plants per year and monitor drug safety after the generic drug has been approved and placed on the market.

It is important to note that there will always be a slight level of natural variability that is medically unimportant, such as there is for one batch of brand-name drug compared to the next batch of the same brand-name product. This variability can and does occur during manufacture, for both brand name drugs and generic drugs. When a drug, generic or brand, is mass-produced, very small variations in purity, size, potency, and other parameters are allowed. The FDA limits how much variability is acceptable.

For example, in a very large research study comparing generic drugs with brand name drugs, it was found that there were very small differences (of approximately 3.5%) in absorption in the body between generic and brand name drugs. Some generics were absorbed a little more, some slightly less. This difference is to be expected and acceptable, either for a lot of brand-name drug tested compared to another lot of the same brand or for a generic drug tested compared to a brand-name drug. As a general rule, the difference between the generic to brand drug comparison was the same as the brand to brand drug comparison.

Why do brand-name drugs and their generic versions look different?

Trademark laws in the United States do not allow a drug or generic drug to have the same appearance as other drugs already on the market. Generic drugs and brand-name drugs share the same active ingredient, but other characteristics, such as color and taste, that do not affect the performance, safety, or effectiveness of the generic drug, may be different.

Why do generic drugs cost less than brand name drugs?

Generic drugs or drugs are only made available after rigorous review by the FDA and after a certain period of time of exclusivity of the brand-name version on the market. This is because new drugs, like other new products, are generally protected by patents that prohibit others from making and selling copies of the same drug. A patent protects the company’s investment in drug development by giving the company the exclusive right to sell the drug while the patent is in effect.

Due to the length of time it takes to bring a new drug to market, this exclusivity period allows pharmaceutical companies to recoup the costs associated with bringing a new drug to market. The FDA also grants certain marketing exclusivity periods for brand-name drugs that may prohibit the approval of generic drugs. Once these patents and marketing exclusivities expire (or if the patents are successfully challenged by the generic drug company), the generic drug can be approved.

Generic drugs also tend to cost less than their brand-name counterparts because applying generic drug manufacturers do not have to repeat the animal studies and clinical (human) studies that were required of brand-name drugs to demonstrate their safety and efficacy. Because of this, the request is called a “new abbreviated drug request”. This, along with the competition between the brand-name drug and multiple generic drugs, is largely the reason why generic drugs cost so much less.

In fact, applications from multiple companies are often approved to market a single product; This creates competition in the market that generally results in lower prices.

The initial research cost reduction means that, although generic drugs have the same therapeutic effect as their brand-name equivalents, they are generally sold at substantial discounts, about 80% -85% less compared to the price of the brand-name drug. According to the IMS Health Institute, generic drugs saved the US healthcare system $ 1.67 trillion between 2007 and 2016.

What standards do generic drugs have to meet to receive FDA approval?

Pharmaceutical companies can submit an Abbreviated New Drug Application (ANDA) for approval to market a generic drug that is the same (or bioequivalent) to the brand name version. The FDA’s Office of Generic Drugs reviews the application to make sure the pharmaceutical companies have demonstrated that the generic drug can be a substitute for the original brand name drug.

Does the FDA monitor generic drugs for side effects or safety issues?

Yes. After FDA approval of any drug, including generics, the FDA continues to review the safety of the drug. The FDA takes several steps to ensure safety and quality before and after marketing a new or generic drug.

The FDA also monitors and investigates reports of negative side effects or other reactions in the patient. Research can dictate changes in the way a product is used or made (both brand-name and generic equivalents).

Due to limited resources, the FDA cannot conduct independent clinical trials and lacks the regulatory authority to require the generic industry to conduct such trials. The FDA, however, continues to investigate reports to ensure that it has all the data on these potential treatment failures and, if necessary, will make recommendations to the public and healthcare professionals. Today, to better understand what can cause problems with certain formulations, the FDA encourages the generic drug industry to investigate such problems, under what circumstances they occurred, and whether they are in fact linked to certain generic drugs.

Where can I find more information about generic drugs?

Talk to your doctor, pharmacist, or other health care provider for more information on generic drugs.

From: FDA.gov

Generic Drugs: Questions And Answers