When you head to the pharmacy to fill a prescription, you are oftentimes offered a generic drug. In fact, 8 out of 10 drug prescriptions filled in the United States are for generic pills. But are these drugs as effective as the brand names that your doctor initially wrote you a script for?
What is a generic drug?
Pharmacist Erik Mogalian notes that a brand name drug is one that was originally discovered and developed by a pharmaceutical company. “ In order for the company to market and sell their product, they must first gain approval from the Food and Drug Administration (FDA) by submitting a New Drug Application. During this documentation, the company submits data to establish a drug’s clinical safety and efficacy. After a drug receives the approval of the FDA, the company that created it is then able to exclusively market and sell it under their patented brand name. A company’s patent on a brand name drug typically lasts for 20 years. Once the patent expires, the drug is eligible to be made into a generic brand.
Melissa Stoppler, M.D., explains that a generic drug is “a copy of a brand name drug that has the same exact intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug.” So a generic drug formula has the same pharmaceutical effects as a brand name product.
What are the differences between generic and brand name drugs?
According to the Federal Food and Drug Administration, generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product. Generic drugs, however, do not always contain the same inactive ingredients as the brand name product so there are some slight differences between the two formulas. These subtle changes have no impact on the effectiveness of a generic drug to perform the same task as its brand name counterpart. By reviewing bioequivalence data, the FDA ensures that a generic product performs the same as its respective brand name product. This standard applies to all generic drugs, whether immediate or controlled release.
Generic drugs perform the same function and are just as effective as their brand name counterparts
Since generic and brand name drugs perform the exact same functions, they can safely be swapped out for one another. And many studies, such as a recent one conducted by researchers at John Hopkins Bloomberg School of Public Health, have found this to be true. John Hopkins concluded that a “generic forms of a biologic drug used to treat rheumatoid arthritis, inflammatory bowel disease and psoriasis” seemed to be just as safe and effective” as the brand name. The study, which was published in the journal Annuals of Internal Medicine, analyzed 19 studies on Inflectra, a generic (or “biosimiliar”) form of Remicade, a pill that treats arthritis and irritable bowel syndrome. The results revealed that the generic versions of Remicade were just as effective and safe as their brand name counterpart. “Biologics are the wave of the future. That’s where more and more of the pharmaceutical market is going in the years ahead,” said lead researcher, Dr. Caleb Alexander, an associate professor at Johns Hopkins and co-director of the university’s Center for Drug Safety and Effectiveness, in an official press release issued by the hospital.
Another study that looked at 38 published clinical trials comparing cardiovascular generic drugs to their brand names found that there was no evidence that brand name heart drugs worked any better than generic heart drugs.
Generic drugs are cheaper
One of the major consumer advantages to opting for a generic drug is that the price tag is often a lot less than that of a brand name prescription. “The major difference between a brand-name pharmaceutical and its generic counterpart is neither chemistry nor quality, but whether the drug is still under patent protection by the company that initially developed it,” says Phillip DeShong, professor of chemistry and biochemistry at the University of Maryland. Once a drug patent has expired, external pharmaceutical companies are able to swoop in and recreate the drug without permission from the developing company and can begin to sell it in a generic form. Since the drug has already been on the market, has passed all the necessary clinical trials, and has been well advertised, companies that are looking to sell a generic version of the drug will face substantially lower development costs — The average cost of developing a new drugs is estimated to be around $1 billion dollars and takes more than 10 years! Thus, producers of generic drugs can sell their products at a lower cost to consumers and still make a profit on the sale.
A different look
While a generic drug will perform the same task as a brand name, it may vary from the original product in its appearance. The color, shape, and size of a medication may be different depending on which company is manufacturing it. So, for instance, if you pick up your prescription for Valtrex, the generic form of Valacyclovir Hydrochloride may appear blue in color, versus the brand name, which is typically white.
When to go brand name vs. generic
As generic drugs are just as effective as brand name, substituting one for the other is perfectly fine. There are some cases, however, where you may prefer one over the other.
- If your insurance covers the brand name: If your insurance covers the brand name and the cost to purchase a brand name vs. generic is the same, then you may want to opt for the brand name that your doctor initially prescribed.
- If you have a specific ingredient allergy: A generic drug may come in a red color, meaning it has been dyed with a substance like Red #40, while the brand name may be white. If you are sensitive to this chemical dye or want to opt for a more natural version, then this is a scenario where you may want to consider purchasing brand name versus generic.
- You believe in the placebo effect: Many consumers feel that the brand name drug is going to work better for them than the generic. While there is no truth behind this, studies have shown that there is a placebo effect to knowing that the drug that you purchase is going to be the one that works best for you.
In 2015, generic drugs made up 88% of prescriptions filled and 28% of total drug spending. That number increased to 89% in 2016. In 2015 alone, generic medicines saved U.S. patients over $227 billion. And as more and more brand name drugs begin to lose their patents, these numbers are only expected to increase, which will allow for more opportunities for consumers to save money on drug prices going forward.