About Generic Drugs
New drugs are drugs that are manufactured and sold first after research and development of new active ingredients and usage methods, and are also called genuine products.
Generic drugs are developed by other pharmaceutical companies using the same active ingredients after the patent period of the new drug has expired. A drug approved by the government.
Although the efficacy and safety of new drugs and generic drugs are the same, there are some drugs that have been improved in size and fragrance to make them easier to swallow using the latest technology. Some tablets have the name of the medicine printed on them to prevent mistakes.
“Generic” is a word that means “common” in English. In Europe and the United States, where the penetration rate of generic drugs is extremely high, when prescribing drugs, the general name (generic name) is often written instead of the name of the product, so generic drugs are called generic drugs. It has become a generic name all over the world.
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Difference from New drugs
The active ingredient, amount, effect, and safety of the new drug and the generic drug are equivalent. Now let me explain what is different.
The difference is the ease of drinking and the price .
Generic drugs are developed with the same active ingredient in the same amount. However, there are differences in taste, shape, color, additives, etc.
For example, it is possible to reduce bitterness by coating the medicine, and to change the size of the tablet to make it easier to swallow. Others are available in jelly form or sheet form that melts in the mouth.
Of course, not only oral medicines, but also external medicines have been improved. Some nasal drops have added viscosity to stay in the nasal cavity for a long time, while some patches are designed to reduce rashes due to their stickiness.
Drugs that have been developed in this way are called “advanced generics.”
The biggest difference is the cost difference. Compared to new drugs, the development period and costs can be significantly reduced . As a result, the selling price can also be reduced.
Generic drugs are widely used around the world because of these many benefits .
Effectiveness, safety and quality
New drugs and generic drugs are basically equivalent in efficacy and safety .
A new drug is a drug that can be said to have established efficacy and safety during an exclusive marketing period of 20 to 25 years. Generic drugs are drugs that have been developed based on the active ingredients and manufacturing methods of new drugs, and have been approved for manufacturing after passing many strict tests.
Generic drug development goes through many stages, from basic research to clinical trials.
First of all, we will investigate sales trends of new drugs and patient trends for indicated diseases. Based on the results of the basic research, we will study whether it is possible to develop equivalent or superior drugs based on the active ingredients of new drugs that can be developed. Clinical trials are then conducted.
How the drug dissolves is important for obtaining the effect of the drug. The effect will be different depending on where it melts.
Dissolution experiments are conducted to measure the dissolution speed of new drugs and generic drugs using acidity and alkalinity.
Even if the ingredients and compounding amounts of new drugs and excipients are different, we conduct bioequivalence tests in the approval review of generic drugs so that the efficacy and safety are the same. We are confirming whether it will be equivalent to the original drug.
A bioequivalence study, also known as a BE study, is a study conducted to prove whether a generic drug is therapeutically the same as a new drug.
This is a study in which new drugs and generic drugs are routinely administered to healthy adults, and whether there is a statistical difference in the blood concentrations of the two drugs.
We also conduct accelerated tests to estimate the stability during the distribution period in a short period of time, and long-term storage stability tests to estimate the long-term quality stability.
Generic drugs are manufactured and sold only after passing through various surveys, research, and tests and obtaining government approval. From this, it can be said that there is no difference in efficacy, safety, and quality between brand-name drugs and generic drugs.
Cheap Reason
The main feature of generic drugs is their low selling price.
It can be purchased at a cost of 30 to 70% compared to new drugs . Low cost does not mean inferior quality. Now let me explain why the price is so low.
First of all, it is said that the development of a new drug generally takes a long time of 9 to 17 years and costs 10 to 20 billion USD.
Even if an effective ingredient is found, it seems that there are many cases in which development is interrupted during the development stage for various reasons, such as it not being compatible with the human body or being highly toxic.
It is said that less than 1/4000 of the ingredients that have been developed are actually approved as new drugs.
Developing new drugs is therefore risky.
In addition, the process up to the release requires a lot of screening and submission of a huge amount of materials, so it takes a lot of time and effort. As a result, the selling price of the new drug is also higher.
On the other hand, the development process for generic drugs is very different. Since the drug is developed using ingredients whose efficacy and safety have already been established , the development period can be shortened to 3 to 4 years, and development costs can be greatly reduced.
As you can see by comparing these, generic drugs have the same quality and can be sold at a lower price. Since we are able to work on formulation research by reducing development costs, we can also improve original drugs and manufacture formulations with added value.
Generic drugs are manufactured based on new drugs that have been developed with a lot of effort and money. It will end up. Patent rights are granted to pharmaceutical companies that have developed new drugs so that the efforts of companies that have invested a large amount of money in research and development over a long period of time will not be wasted.
It is a right to prevent other pharmaceutical companies from imitating the manufacturing method using the same ingredients for a certain period of time. A pharmaceutical company that has developed a new drug must recover development costs during the exclusive sale under this patent right.
Once the patent expires, other pharmaceutical companies will be able to develop drugs using the same active ingredients and manufacturing method, and generic drugs will be born.
When developing generic drugs, it is possible to omit the clinical trials that are being conducted during the development stage of new drugs.
Based on these facts, generic drugs can be obtained at a low price because the development costs can be greatly reduced compared to new drugs .
What is a patent
There are four types of pharmaceutical patents.
Substance patent
A patent granted when a substance with a new chemical structure that can be used as a drug is discovered.
Process patent
A patent is granted when a new manufacturing method for an existing drug is discovered.
Formulation patent
A patent is granted when it is discovered that it is effective to formulate a new formulation such as capsules from tablets of existing pharmaceuticals.
Use patent
A patent is granted when a new efficacy or effect of an existing drug is discovered.
Of these four types of patents, the most important and valuable to pharmaceutical companies is the “substance patent.” However, it takes a lot of money and time to obtain substance patents, so we are increasing our assets with other patents.
The term of a patent is 20 years from the date of filing.
In the case of pharmaceuticals, an extension of up to five years is permitted , considering that tests to establish safety and national examinations may affect the duration of the patent right. During the term of the patent, the patentee’s pharmaceutical company has the exclusive right to manufacture and market the drug.
After the expiration of the patent term, it will become a property of the people, and it will be possible to manufacture and sell generic drugs .
Demand for Generic Drugs
Generic drugs have been established as effective and safe as new drugs, and have many advantages such as being available at a low price . Even in USA, the penetration rate of generic drugs is on the rise, but it still remains at 92% (aggregated figure of drug price survey in September 2016).
Globally, the penetration rate is 92% in the United States, 83% in Germany, and 73% in the United Kingdom.
When a foreigner receives medical treatment, it costs a lot of money. For this reason, it is said that the spread of generic drugs, which are available at low prices, has progressed in order to reduce the medical burden.
A manufacturing powerhouse of generic drugs
When it comes to generic drugs, many people think of the United States. Certainly, considering the high penetration rate, the United States can be said to be a generic powerhouse.
However, depending on how you look at it, India can be said to be a generic powerhouse.
India can be said to be a generic powerhouse because of its large production and export volumes.
In terms of export value, 171.5 billion to the United States, 110.2 billion to Asia, 100.2 billion to Europe, 72.7 billion to Russia, Ukraine, etc., 36.1 billion to the Middle East, 85.7 billion to Africa, and 5.6 billion to Oceania. and become the world’s largest exporter.
The reason why India has become a generic powerhouse is related to its unique patent legal system.
There was a time when substance patents were not applicable in India.
The fact that there are no substance patents means that even if the same active ingredient is used as the new drug, it can be developed as long as it is recognized that the manufacturing method is different. This has inevitably led to an increase in the number of companies developing generic drugs in India, leading to the current production and export volumes.
Although it is a unique patent system. It has been proven to be equivalent in efficacy, safety and quality, and is recognized all over the world.
The reason why India has taken such a system seems to be aimed at helping people in poor countries around the world .
Doctors Without Borders is especially important for Indian generic drugs.
It is an organization that works to protect the lives of developing countries and refugees, and generic drugs are indispensable medicines.
In particular, almost 90% of medicines such as anti-AIDS drugs, tuberculosis medicines, wound medicines, anti-suppuration medicines, and vaccines are generics. That is why India is also called the “pharmacy of the developing world”.
Generic medicines made in India have contributed to the relief of many people . From the current situation, it can be said that it is indispensable in the world.