Generic drugs vs. brand name drugs
In recent years, generic drugs have gained a significant place in the global pharmaceutical market, in contrast to traditional brand-name drugs distributed by the main laboratories in the sector. These drugs, which contain the same active ingredients as their brand-name versions, therefore promise identical effectiveness but at a much lower cost, since they are not subject to the margins of the major brands or to import costs. In addition, they can be manufactured by multiple national laboratories, which significantly reduces their price.
The emergence of generics has been driven by governments and official health agencies, motivated by the need to reduce health costs for both public systems and patients, without compromising the effectiveness or safety of treatments. These actors have supported their use, arguing that generics meet the same quality and regulatory standards as brand-name drugs.
Although they may seem like identical medications because they have the same active ingredient, in reality, they are not and you need to know when one or the other is best for you.
If reading this makes you anxious thinking that you take many generic drugs and you thought they were the same, don't worry, generic drugs are safe and are contributing to access to medicines for all social classes and all countries, which with the cost of patented brand name drugs, would never have happened.
Origin of generic drugs
The origin of generic drugs dates back to the early 20th century, but their true rise and formal regulation occurred in the late 1970s and 1980s. Here I explain a little about how they emerged and how they were consolidated:
- In the early 20th century, brand-name drugs dominated the market, protected by patents that gave large pharmaceutical companies exclusivity to market a drug for a limited period (usually 10 to 20 years). During that time, other companies could not manufacture or sell versions of the same drug.
- As patents began to expire, the possibility arose for other companies to produce versions of the drug without having to invest in the costly research and development process, that is, by directly plagiarizing existing brand-name drugs. These generic drugs, which contained the same active ingredients as the originals, began to gain ground as a more affordable option, but without clear regulation, which made it difficult for them to expand and be accepted by all audiences.
- The real turning point came in 1984 in the United States, with the passage of the Hatch-Waxman Act (also known as the Drug Price Competition and Patent Recovery Act). This law allowed generic drugs to come to market more quickly, as they did not need to go through the extensive and expensive clinical trials that the original brands had undergone. Instead, they were required to prove that they were bioequivalent (i.e. that they released the same amount of the active ingredient into the body and in a comparable period of time as the brand-name drug).
- Following the Hatch-Waxman Act, other countries began to adopt similar regulations. The World Health Organization (WHO) also promoted the use of generic drugs, especially in developing countries, where their lower cost was vital to guarantee access to essential medical treatments.
- Over the years, generic drugs have gained acceptance among both healthcare professionals and patients. Although there was initially skepticism about their effectiveness, strict regulations and bioequivalence testing ensured that they offered the same quality and safety as brand-name drugs. Today, generics account for a significant share of the global pharmaceutical market, contributing to lower healthcare costs in many countries.
So why aren't they the same?
Broadly speaking, a medicine is made up of two main components: the active ingredient and the excipients. The active ingredient is the component responsible for the therapeutic action of the medicine. That is, it is the ingredient that exerts a pharmacological or physiological effect on the body to treat, prevent or diagnose a disease. For example, in an ibuprofen tablet, ibuprofen is the active ingredient, as it is the substance that acts to reduce pain or inflammation.
On the other hand, excipients are inactive substances that accompany the active ingredient in a medicine. Although they do not have therapeutic effects by themselves, they are essential to facilitate the administration, stability, absorption, taste, shape or preservation of the medicine. For example, excipients are what allow a tablet to remain compact or a syrup to have a more acceptable taste. In an ibuprofen tablet, excipients may include lactose (as a diluent) and magnesium stearate (as a lubricant), among others.
When a generic drug is manufactured, it is ensured that it contains the same active ingredient and the same quantity as brand-name drugs, which guarantees its therapeutic effectiveness. Excipients, however, may vary between brand-name and generic versions, but they must always comply with safety and quality regulations. These differences in excipients rarely affect effectiveness, although in certain cases they may influence patient tolerance or experience, since they are not the same, although they have similar effects for most audiences, particular situations of each patient can cause these differences to be key in the treatment of each one.
Here are some common cases:
Allergies or intolerances to excipients
Some branded medications do not contain lactose as an excipient, while their generic versions may contain it. If a patient is lactose intolerant or allergic to any of the ingredients, they may experience gastrointestinal side effects when taking the generic, such as stomach upset or diarrhea. This effect is quite common in some anti-inflammatory drugs.
Absorption rate
In certain medicines with extended-release formulations, such as antidepressants, antidiabetics, hypoglycaemics or epilepsy medicines, excipients control the release of the active ingredient. If the excipients differ in a generic, it may affect how the medicine is absorbed or how quickly it enters the system, producing different effects. For example, in hypoglycemic agents: if the excipients cause the release to be faster than your intestine tolerates, your body may react with gastrointestinal discomfort (usually mild).
Posology
In some groups of medicines, variations in the excipients may affect their bioavailability or absorption capacity, so that even if the effect is the same and the patient tolerates them well, a different dose may be necessary depending on whether the medicine is generic or not.
Administration
In some cases, delivery devices may differ between brand-name drugs and their generic versions. This may be particularly important for inhaled medications, where the shape of the applicator through which the medication is delivered may affect its effectiveness.
Disclaimer
As you may have noticed, we have avoided talking about specific brands or laboratories throughout the article, since although there are known cases of many of them, it is something that is very specific to each patient, so it is important not to create unnecessary alarms in readers or fear of any type of medication, whether generic or brand name.
The purpose of this article is to explain why some patients may notice differences between brand name and generic drugs and to let them know that if a drug makes them feel bad, they can ask their doctor to prescribe the same active ingredient from another brand or laboratory.
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