What is the Difference Between Genuine Drugs, Generic Drugs, and APIs?

Genuine Drug-What is a Genuine Drug?

Genuine medicine is a concept unique to China, and it is called original research drug in European and American countries.

It refers to the original research and development of new drugs, which have been approved for listing after tens of thousands of compounds and rigorous clinical trials.

It takes as short as 5 years, as long as 15 years of research and development time and hundreds of millions of dollars of investment, so the price of the original research drug is very high as soon as it goes on the market, and this is also for a reason.

The general process for the original research drug to be marketed:

Project establishment (4 months)-preclinical research (9-24 months)-clinical research application (more than 1 year)-clinical trial approval-clinical research (3-5 years)-production application (1 year) -n years)—review and on-site inspection after acceptance of the notice—approved for production and listing (about 6 months)—monitoring period

This is also the reason why genuine drugs will be regarded as “expensive drugs”, and the cost invested during the period will take some time to recover. For some genuine medicines that are already on the market in China, if the family economy allows, the genuine medicines can be given priority. If long-term treatment can no longer afford genuine drugs, generic drugs can be considered.

For example: 9291 (Ositinib) was only listed in China in 2017 this year. It is priced at 51,000 January.

It has a patent protection period of 20 years, that is to say, from 2017 to the next 20 years, China cannot imitate its medicines, and the prices will always be such high.

So why can Irisa be copied? Iressa also passed the patent protection period this year, so Chinese pharmaceutical companies began to imitate, but his price and drug quality cannot be compared with India’s.

Genuine drugs are generally approved for marketing after screening thousands of Chinese compounds and rigorous clinical trials; it takes about 15 years of research and development time and hundreds of millions of dollars. Currently, only large multinational pharmaceutical companies have the ability to develop them; Such drugs are considered superior in quality and enjoy policy protections such as individual pricing.

Generic Drugs-What are Generic Drugs?

A generic drug refers to a generic drug that is the same or similar to the original drug (original drug) in terms of dosage, safety and efficacy, quality, effect, and indications.

Because of the patent protection of tumor drugs in China, it is difficult to see domestic tumor generic drugs. However, India, the world’s major imitation country, has simply ignored the intellectual property choices of pharmaceutical companies in Europe and the United States because of the creation of the “Medical Patent Compulsory Demand Certificate”, and then imitated and sold some oncology drugs, and the price was far from the genuine drugs.

Indian law stipulates that its own pharmaceutical companies can imitate global drugs for their citizens.

And the US FDA also approved 650 Indian pharmaceutical companies to export generic drugs to European and American countries.

For example, AZD9291 (Osimertinib), produced by AstraZeneca Pharmaceuticals in the United Kingdom, sells for around 60,000 yuan in the United States. Many ordinary families want to use the medicine, but they have a lot of heart but not enough money. Generic drugs, on the other hand, cost only a few thousand yuan on average, bringing hope to many families. Of course, many patients are heartbroken, but India also has fake medicines.

The fake medicines are not produced by Indians, but the Chinese go to India to open a small illegal processing plant, and the fake medicines are produced and sold to China.

Therefore, when choosing generic drugs, you must choose a legal and compliant overseas medical institution or company. You can go to India and prescribe the drugs with a prescription or choose to have patients who go to India to help buy them. This is to ensure the safety of the drugs. Effective method.

API-What is an API?

The raw material medicine is actually the upstream of the normal medicine. Strictly speaking, the raw material medicine is not directly “eaten” by the patient, because it is not a medicine, but like other chemical products, it is just a raw material.

To put it more simply, the raw material drug contains the same or similar active ingredients as the genuine drug, but the price difference with the genuine drug is huge and is sought after by many patients. However, no one can guarantee the efficacy of the drug. In fact, this sensitive issue is also a lot of patients. all know.

The “raw material medicine” is actually the raw material of normal medicine, and it is not directly “eaten” for patients, because it is not a medicine! But like other chemical products, they are just raw materials.

For a drug, the active ingredient of the drug is the main ingredient of the drug, and the other ingredients are called “excipients”. The raw material drug has the same or similar active ingredients as the original drug, but has not undergone the preparation process.

The bulk drug is a kind of compound, because it is impossible for the compound to have perfect physical and chemical parameters to achieve the greatest effect in the complex environment of the human body, so the regular original research drug needs to use various excipients and dosage forms to achieve the curative effect.

For example, afatinib and ossitinib are life-saving drugs for lung cancer patients. When they were not approved for marketing in China, the raw materials were very hot.

However, these small-molecule targeted drugs have special acid-base coefficients and require precise dissolution in the preparation, so as to ensure that they disintegrate at the correct time when they reach the gastric acid environment, dissolve at the correct speed, and obtain the appropriate absorption rate.

However, self-made preparations may disintegrate too early or too late due to differences in excipients, tableting, etc. If they are too early, they will cause mucosal irritation to the esophagus and stomach, and too late will cause incomplete absorption in the stomach and enter the intestinal tract. The pH environment is not easy to absorb, and the drug dosage is difficult to achieve, which may affect its therapeutic effect.

Many patients use raw materials because of price factors or the inability to buy original research drugs in China. This situation may not only fail to exert the efficacy, but also cause other undesirable results due to improper use.

Therefore, patients should carefully consider the use of APIs.

In fact, in the anti-cancer circle, some patients use raw materials directly for anti-cancer. (This is extremely not recommended) For various reasons, the speed of new anti-cancer drugs in China is very slow and the price is very expensive (you can’t eat it for a few months after selling a house), and many people consider eating chemical raw materials in order to survive. .

“Targeted drugs can’t take the API directly. Targeted drugs are mainly used in the preparation process to achieve the targeted delivery step of the drug. If the targeted API is taken naked, the drug will only run in the body according to the normal digestion process. It will be transported to the diseased part.”

Another point is that the chemical formula of drugs is public. Everyone can see its chemical formula when you open the drug manual. With this chemical formula, anyone with a little knowledge of chemistry can synthesize it, so there are many in China. In fact, a few people closed the door to synthesize the raw materials of the drug by themselves, so the quality is even more unguaranteed.

Why is there such a Big Difference in Prices Between Genuine Drugs and Generic Drugs?

For the original drug, research and development is an extremely complicated process. From development to market, it needs to go through clinical studies such as high-throughput screening, physical and chemical properties, in vitro screening, and in vivo screening; phase I phase II and phase III clinical research; here It can be listed only after registration.

The research and development of an original drug requires an average of 4,000 chemical structures, which takes 10-15 years, and the average investment is as high as US$300-500 million.

But as far as generic drug manufacturers are concerned, they have saved the cost of drug R&D and marketing. On average, a generic drug can be sold in 3-5 years, and the cost is generally less than US$240,000. The natural price of this low-time-consuming, low-cost, and low-promotion drug is also much lower than the original research drug.

Regardless of whether it is a generic drug or an original drug, it is the luckiest thing for cancer patients to have a drug that suits their condition. Many patients choose generic drugs because the original research drugs are more expensive.

Generic drugs are not only much cheaper than the original drugs in terms of price, but also in terms of efficacy, many patients have obtained good curative effects and their conditions are under control, such as osimertinib and crizotinib used by patients with lung cancer.

However, biologics such as PD-1 (Opdivo and Keytuda) have no approved generic drugs, and now there are only original research versions. Patients and their families should pay attention to this.

In fact, in many countries and regions, doctors’ prescriptions only contain the generic name of the drug (not including the specific manufacturer), and the pharmacist can help patients choose generic drugs that are approved by the local drug administration to help patients while guaranteeing treatment. Cost savings, the use of generic drugs is protected and encouraged.

Due to the continuous advancement of pharmaceutical technology, some old drugs that have been used for many years have been imitated on a large scale and the preparation technology has been continuously improved. In clinical use, the distinction between original research drugs and generic drugs has even been neglected.

For patients with malignant tumors, careful selection of drugs from regular sources is the top priority. I hope everyone will keep their eyes open during the selection process, stay away from APIs, and rationally choose original drugs and generic drugs within the scope of economic affordability.