Are Generics Worse than Brands?
The generic versions of the medication always create a lot of debates and rumors. The supporters claim that generics allow treatment access to a larger group of people. Their opponents put the use of generics somewhere next to Internet piracy and watching the movies online. They also throw the arguments like “generics are ineffective” and “generic drugs stalls the R&D”.
Here we tried to clarify the situation by putting together some myths and facts about generic drugs.
Generics are not the same as the branded drug?
According to the FDA, “a generic drug is identical – or bioequivalent – to a brand
name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.” Generics have the same function of the brand product, but come at a lower cost. So yes, generics are the same as the branded drugs, but the price and packaging is not the same.
Generics are not as effective as the branded formulation
In order to gain FDA approval, generic manufacturers must prove that their product:
- contains the same active ingredients as the brand,
- is identical in strength, dosage form, and route of administration,
- have the same indication as the brand,
- is bioequivalent to the brand,
- meets the same batch requirements for identity, strength, purity, and quality as the brand,
- is manufactured under the same standards of good manufacturing practice regulations that the FDA requires for brand products.
It means that the efficiency of the generics is the same as the efficiency of the brands.
FDA requires generic drugs have the same high quality, strength, purity and stability as brand-name drugs.
Generics don’t look the same as branded drugs.
Quite often some existing patents and trademark regulations prevent generic manufacturers from developing a product that looks identical to the brand, be it the size, shape or color. While there can be similarities in appearance between the brand and the generic, the generic medicine cannot match the brand exactly. Even though they may look different, generic products maintain the same safety and efficacy as the brand.
Generics don’t require the same level of animal studies as the branded drugs.
In case of generics, it is not necessary to repeat the discovery of the formulation or pre-clinical and clinical studies. Also, marketing investment is much less: generic firms generally don’t do advertising and promotion.
This is often the reason why generic drugs are less expensive.
Would the fact that the animal and human studies weren’t done mean that generics are dangerous? Not really, because the bioequivalency requirement proves that the drug is exactly the same (same chemical formula, molecule, etc.) as the one that was already tested. Since the substance is exactly the same, the effect it produces on animals and in clinical studies would have been exactly the same.
The review process of brands and generics are summed up in the table below.
Brand Name Drug vs. Generic Drug Review Process
|Brand Name Requirements||Generic Requirements|
|1. Chemistry||1. Chemistry|
|2. Manufacturing||2. Manufacturing|
|3. Testing||3. Testing|
|4. Labeling||4. Labeling|
|5. Inspections||5. Inspections|
|6. Animal Studies||6. Bioequivalence|
|7. Clinical Studies|
If the generics are not FDA approved, they are either not safe or not effective.
FDA approval certifies that the generic is a quality medication, safe, effective and equivalent to the brand. However, a simple fact that the drug isn’t FDA approved doesn’t necessarily mean that it isn’t safe to use or that it is less effective. In reality, there are many generics produced outside of the US that are approved by the dedicated governing body of their country and are just as good as the brands.
Let’s look at the example of generics for new hepatitis C drugs: sofosbuvir and sofosbuvir – ledipasvir combo. For the patent reasons these generics won’t be FDA approved for a while, but would that mean that they are not safe or not effective?
According to European Association for the Study of the Liver and to the results of The International Liver Congress™ 2016 in Barcelona, Spain, the affordable hepatitis C generics are equivalent to branded formulations.
This means that the generics for hepatitis C treatment that are currently produced in India are just as safe and effective as the brands, but existing patent wouldn’t allow their production and distribution in the US.
The explanation is that new antivirals for hepatitis C treatment were discovered (and patented) only recently. So, despite the existence of generic drugs in India and all the efficiency of these formulations, it will take some 20 years for the generic hepatitis C drugs to hit the US market. (And until this time, the price of those drugs in the US, even if it will be gradually decreasing, is still likely to remain sky-high.)
Doctors Without Borders have many examples where generic drugs are used safely to help many people in poor countries to fight the diseases, but for patent reasons these generics can’t be FDA approved yet.
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Patents and FDA approval: how are these two related?
FDA claims that they approve a generic drug on the first day it legally can do so. At the same time, not every brand-name drug has a generic drug. How so?
The thing is, when new drugs are first invented, they are protected by intellectual property patents – for 20 years in most cases. The patent doesn’t allow anyone else but the inventor of the drug to make and sell it.
Other drug companies can start producing a generic version of the drug only once the patent expired. Only then the company can have this drug tested and submit it for FDA approval. Once the approval is granted, the drug can be legally distributed in the US.
This process is graphically explained in the chart below.
Generics vs Brands: Summing it up
In the US about 70% of the prescription drugs sold today are generic drugs. Generics allow significant cost-saving options in developed countries, and are the only option for the majority of the 3rd world.
The generic industry is very important for providing low cost medicines in the developing world, especially for the regions like Sub-Saharan Africa, where the burden of HIV, HCV and TB is particularly high. In the last decades, patents and intellectual property restrictions are posing more and more problems for developing nations.
The situation gets worse when the concept of generic drugs is misunderstood. Sometimes big pharmaceutical companies are to blame for the rumors about generics.
It is important that the customers understand the difference between the brands and the generics and buy generic drugs to support the generic manufacturers when it is possible.