As a busy clinician, have you ever looked at the list of generic vs brand name drugs in your EMR and wondered if it matters which one you pick? Has a patient ever asked you which over-the-counter option to choose? Has a patient told you the generic option did not work for them?
It is usually not possible to know at the outset how the patient’s insurance coverage (or lack thereof) will affect pricing, but the use of generic medications saved the US healthcare system an estimated $373 billion in 2021.
Here is some information to help you understand the similarities and differences between generic vs brand name drugs so you can feel confident choosing medications and addressing patient concerns.
Recommended course: Management Of Drug Challenges: Generic vs Branded Drugs, 2nd Edition
Generic vs. authorized generic
While it may seem like petty semantics, there are two types of generic medications: generic and authorized generic. A generic medication is commonly understood to be a copy of the original drug that is usually developed. It is marketed by a different company after the patent protection of a branded medication expires.
By law, generics contain the same active ingredients but may have different inactive ingredients, such as binders. Companies producing generic options must prove that the medication is bioequivalent to the original, and file an abbreviated new drug application with the FDA.
They do not have to repeat animal or human clinical trials. Generics may demonstrate up to a 20% difference in pharmacokinetics (absorption, distribution, metabolism, and excretion) without concern for a relevant clinical difference.
Authorized generics are the identical medication remarketed with a different name, often by the same company that holds the patent for the branded drug, but sometimes by a different company with permission. Like regular generics, authorized generics may have slight differences, such as the appearance of the medication.
Authorized generics may be made and sold at the same time as the brand name product. They may or may not be significantly cheaper. Because it is considered identical, it is approved under the original new drug application and no new research and development activities are required.
Since generic and authorized generic medications do not require research, development, testing, and trials like new medications, they are generally cheaper. However, market pressures can cause prices to rise, even for medications that have been generic for years.
For example, the recent penicillin shortage caused penicillin prices to spike despite it being the oldest manufactured medication available. There is criticism that pharmaceutical companies use branded generics to drive profits without investing that money in research and development. This is purportedly the reason that drug costs are so high, which contributes to the high cost of healthcare in general.
Complicating the picture further, some patients on Medicare Part D plans may have better coverage for branded medications due to loopholes and discounts provided by the pharmaceutical companies. While generic medications are typically more affordable, patients may need to work with their insurance companies and local pharmacist to determine the best option.
Safety, efficacy, and bioequivalence
Both generic and branded medications undergo rigorous testing and scrutiny by regulatory authorities to ensure safety, efficacy, and bioequivalence. Patients who experience a difference between the branded medication and the generic medication may be experiencing the “nocebo effect.” This is the idea that believing something does not work leads to reported side effects or lack of perceived efficacy.
It is also possible for patients to be intolerant of inactive ingredients leading to allergic reactions or adverse symptoms. Desai et al (2019) analyzed claims data for 3.5 million patients to compare authorized generics and brand name products for eight commonly used medications for chronic disease and found comparable clinical outcomes.
Other studies have concluded that generic and branded direct-acting antivirals for hepatitis C are equally effective with a large difference in cost. Furthermore, a systematic review and meta-analysis of cardiac drugs came to the same conclusion.
Switching to generic
Some clinicians may feel disinclined to have patients switch to generic versions of medications with a narrow therapeutic index, such as those used to control seizures. Studies examining the differences in outcomes between branded and generic seizure medications, warfarin products, and levothyroxine have generally concluded the generic products produce similar results.
Study authors suggest that some reported differences may be related to patient adherence. However, other confounders may contribute. Generally, clinicians should feel comfortable counseling patients to expect the same results and encourage adherence despite differences in appearance but should use extra caution with narrow therapeutic index medications.
In conclusion, the availability of generic, authorized generic, and branded medications can be confusing for both clinicians and patients. Multiple factors affect pricing including market pressures, pharmaceutical company practices, and medication ingredients.
Authorized generic medications are essentially identical to the original medication but may not come with a significant price break. Generic medications have slight differences in formulation but are still required to show bioequivalence.
Large studies have demonstrated equivalent clinical outcomes when comparing patients taking generic and branded name medications, and perceived lack of efficacy may be related to patient factors including the nocebo effect. For most patients, generic medications increase access and decrease cost without sacrificing quality.
Clinical pearls in practice
Generic medications are considered bioequivalent and can be directly substituted for branded medications in most cases.
Clinicians can contribute to healthcare cost savings by prescribing generic options and educating patients. State laws allow pharmacists to substitute a generic for a brand name medication unless the prescriber specifies the brand name.
If there is a reason the patient needs the brand name, be sure to specify in the prescription. Most medications can between switched from brand name to generic or back without an issue.
Special caution should be used with narrow therapeutic index medications such as warfarin, levothyroxine, digoxin, and seizure medications.
- Abozeid et al. (2018). High efficacy of generic and brand direct acting antivirals in treatment of chronic hepatitis C. International Journal of Infectious Diseases, 75, 109-114. Doi:10.1016/j.ijid.2018.07.025
- Brito JP, Ross JS, Sangaralingham L, Dutcher SK, Graham DJ, Wang Z, Wu Y, Yao X, Smallridge RC, Bernet V, Shah ND, Lipska KJ. Comparative Effectiveness of Generic vs Brand-Name Levothyroxine in Achieving Normal Thyrotropin Levels. JAMA Netw Open. 2020 Sep 1;3(9):e2017645. doi: 10.1001/jamanetworkopen.2020.17645. PMID: 32997127; PMCID: PMC7527873.
- Desai RJ, Gopalakrishnan C, Dejene S, Sarpatwari AS, Levin R, Dutcher SK, Wang Z, Wittayanukorn S, Franklin JM, Gagne JJ. Comparative Outcomes of Treatment Initiation With Brand vs. Generic Warfarin in Older Patients. Clin Pharmacol Ther. 2020 Jun;107(6):1334-1342. doi: 10.1002/cpt.1743. Epub 2020 Jan 19. PMID: 31872419.
- Desai RJ, Sarpatwari A, Dejene S, Khan NF, Lii J, et al. (2019) Comparative effectiveness of generic and brand-name medication use: A database study of US health insurance claims. PLOS Medicine 16(3): e1002763. https://doi.org/10.1371/journal.pmed.1002763
- Hansen, R., Qian, J., Berg, R., Linneman, J., Seoane-Vazquez, E., Dutcher, S., Raofi, S., Page, C. and Peissig, P. (2018), Comparison of Outcomes Following a Switch From a Brand to an Authorized Versus Independent Generic Drug. Clin. Pharmacol. Ther., 103: 310-317. https://doi.org/10.1002/cpt.591
- Holtkamp, M, Theodore, WH. Generic antiepileptic drugs—Safe or harmful in patients with epilepsy? Epilepsia. 2018; 59: 1273– 1281. https://doi.org/10.1111/epi.14439
- Leclerc, J., Thibault, M., Midiani Gonella, J. et al. Are Generic Drugs Used in Cardiology as Effective and Safe as their Brand-name Counterparts? A Systematic Review and Meta-analysis. Drugs 80, 697–710 (2020). https://doi.org/10.1007/s40265-020-01296-x
- Statista. Savings through generic drug usage in the United States from 2008 to 2021.https://www.statista.com/statistics/277492/savings-through-generic-drug-usage-us/
- Sydney Costantini, Rochelle P Walensky, The Costs of Drugs in Infectious Diseases: Branded, Generics, and Why We Should Care, The Journal of Infectious Diseases, Volume 221, Issue 5, 1 March 2020, Pages 690–696, https://doi.org/10.1093/infdis/jiz066
- U.S. Food and Drug Administration. Generic drugs: Questions and answers. https://www.fda.gov/drugs/frequently-asked-questions-popular-topics/generic-drugs-questions-answers