Are generic drugs as effective as their brand-name counterparts? Here's what you need to understand.

 

Approximately 90% of prescriptions dispensed in the United States are for generic versions of drugs rather than the branded counterparts developed by the original pharmaceutical company, as reported by the U.S. Food and Drug Administration. Despite this prevalence, many individuals may be unaware of whether the medication they obtain from the pharmacy is generic or branded, the distinctions between the two, and whether it holds any significance.

According to Mike Sevilla, a physician at the Family Practice Center of Salem in Ohio, "Generic medications contain the same active ingredient as the brand-name drug," emphasizing that generics are generally intended to have similar efficacy to their branded counterparts.

While generic and brand name drugs are expected to exhibit comparable effectiveness, variations, particularly in terms of cost, do exist. Here's what you should be aware of.

What sets them apart?

A brand name drug is produced by the pharmaceutical company that created and sought approval from the FDA, holding the patent for the chemical compound. Conversely, a generic drug is crafted by other companies once the patent expires, with the active ingredient— the compound addressing a condition—remaining consistent in both. "Generic medications aren't an exact replica of their name-brand counterparts, but they come very close," notes Sevilla. Variances primarily revolve around the inactive ingredients they incorporate. These components, such as alcohol, gelatin, saccharin, or sugars like galactose or lactose, do not impact the drug's therapeutic properties. Instead, they are included in the drug formulation to ensure consistency, preserve the drug, facilitate transportation, or introduce color or flavor. Generally, the only concern arises if a patient has an allergy, for instance, someone requiring a gelatin-free drug due to a gelatin allergy. To comply with trademark laws and prevent infringement, generic drugs are mandated to have distinct appearances from the brand name, often differing in size, shape, color, or even taste. However, for them to be marketed as the claimed drug, the FDA insists on their "bioequivalence" to the original brand name drug. Bioequivalence ensures that the products are equivalent in terms of speed and efficacy in achieving their intended effects.

What drives the higher cost of brand name drugs?

Generic alternatives are significantly more affordable, typically costing around 80 to 85 percent less than their brand name counterparts. Despite this cost difference, a substantial portion of drug spending in 2022, approximately four out of five dollars, went towards name-brand prescription medications, accounting for just 9 percent of all prescriptions sold.

The cost disparity extends beyond the drug price itself. Insurance companies often impose lower copays for generic drugs, reflecting their reduced expenditure. In 2022, the average copayment for patients was approximately nine times higher for brand-name medications compared to generic alternatives. Notably, data from 2022 revealed that 92 percent of copays for generic drugs were under $20, whereas only 53 percent of brand name medications had a cost below $20.

Looking at the broader perspective, the adoption of generic drugs over brand name versions led to substantial savings in healthcare costs for Americans, amounting to nearly $2 trillion between 2009 and 2019.

The affordability factor also influences patients' medication adherence, as generic medications are more cost-effective. According to a 2019 report from the Association for Accessible Medicines—the most recent data available on this matter—patients on brand name drugs were over three times more likely to discontinue picking up their medications compared to those using generics.

Which option boasts greater effectiveness?

Despite prevalent beliefs among patients and physicians suggesting differences in efficacy, Ferreri dispels such notions as myths.

Numerous studies have systematically compared the safety and efficacy of generic and brand name drugs, consistently revealing no substantial differences. A comprehensive study, encompassing over 1.3 million individuals who transitioned from one type to the other, found that outcomes were largely indistinguishable between generic and brand name medications for most drugs.

While variability may exist among different batches of generic drugs, a similar variation can occur with batches of brand name drugs. The FDA tightly regulates the permissible extent of variability in both cases. After a generic drug enters the market, ongoing monitoring of safety and efficacy is conducted by the FDA through the Therapeutic Inequivalence Action Coordinating Committee, which reviews reports of treatment failures to assess the need for market withdrawal.

A 12-year study examining bioequivalence revealed that the body's absorption of name brand versus generic drugs differed by only approximately 3.5 percent.

However, this slight percentage variance may be relevant to specific patient subgroups. A systematic review of cardiovascular drugs suggested a slightly elevated risk of hospital visits among patients using generics, though the authors cautiously acknowledged insufficient evidence to draw firm conclusions due to a lack of personal data about patients, such as socioeconomic status, race/ethnicity, or geography.

Delivery method disparities, even with identical active ingredients, could be significant. For certain extended-release medications for attention deficit hyperactivity disorder (ADHD), a small study identified differences in children's symptoms between a generic version and a brand name drug, which utilized a distinct method for gradually releasing the drug's active ingredient.

In some instances, research has indicated an uptick in doctor visits, hospitalizations, or "breakthrough seizures" when epilepsy patients switch from a brand name drug to a generic. However, conflicting research has suggested that epilepsy patients experienced fewer seizures on generic drugs compared to brand name alternatives.

Sevilla acknowledges patient anecdotes in his practice, where some assert that generic medications are less effective than their brand name counterparts. Consequently, he opts to keep such patients on the brand name drug, even if a generic option is available.