The Difference Between Generic Drugs and Original Drugs - BiopharmaDirect

The Difference Between Generic Drugs and Original Drugs

People may often hear about the different types of medicinal drugs, such as generic drugs, original drugs and imported medicine. But some may not know the differences between them. This article will elaborate the similarities and differences between them.

What are generic drugs and original drugs?

Generic drug

This refers to a generic product that is the same as a brand-name drug in terms of dosage, safety and efficacy, quality, effect and indications.

Original drugs

Original drugs refers to drugs that have been approved for marketing after tens of thousands of compounds testing 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 the so-called original drugs.

Is the generic drug the same as the original drug?

In fact, drugs can indeed be imitated, and some countries are vigorously promoting this practice because it can save huge R&D costs. But people are afraid if the generic drugs are exactly the same as the original drugs and if they have the same therapeutic effects.

Original drug, as the name suggests, is a new drug that has never been created before. It has a patent period of 20 years and hence is also called a patent drug. However, when the patent expires, other drug manufacturers can start produce this new drug, and the drug they produced is called generic drug.

Generic drugs are manufactured based on the formula of original drugs, and their effective ingredients and indications are basically the same. The production of generic drugs does not require innovative research, design, and investment of a lot of time and money, and can often be produced in two or three years, so its price is often one-third or even one-sixth of the original research drug. Therefore, in order to solve the problem of the availability of medicines for the common people, countries all over the world are vigorously promoting generic drugs just simply because they are cheap enough. However, the development of original drug needs a lot of investment, and it takes a lot of time and money to carry out clinical trials, so the price is often much higher.

What are the differences between generic drugs and original drugs?

In spite of the similarities between generic and original drugs, some researchers still believe that slight differences also exist between the two, which are reflected among the following areas:

1. Clinical trials of drugs

The original research drug needs to undergo phase 4 clinical trials. Among them, phase 1 clinical trials are carried out in healthy people, phase 2 and 3 are carried out in patient populations, and phase 4 clinical trials will be carried out after marketing. This entire process often takes more than ten years and involves thousands of patients in order to comprehensively examine the effectiveness and safety of a new drug.

Generic drugs only need to conduct a small-scale "bioequivalence test" to examine the rate and extent of absorption between it and the corresponding original drug. As long as it is 80%-125% of the original drug, it can be assumed that it has the same efficacy as the original drug. Also, the experimental population is mostly young healthy people instead of patients.

2. Crystal form

Clopidogrel is commonly used for the treatment of cardiovascular diseases. Although the active ingredients of the original drug clopidogrel and the generic drug clopidogrel are the same, their "crystal forms" are different. For drugs, if the crystal form is different, the absorption and stability will be different as well. For example, some original drugs can be valid for three years, and some generic drugs can only be stored for two years. The reason for the difference is that their crystal forms are different.

3. Excipients

Except for the active ingredient of a medicine, there are also auxiliary ingredients that help to form drugs. For example, in common capsule medicine, the outer shell is the excipient. As a matter of fact, although the excipients are considered to be auxiliary, they play an extremely important role in terms of stability, absorption, solubility, and oxidation resistance of a drug.

4. Impurities

The drug production process inevitably contains certain impurities, and will affect the efficacy and side effects of the drug. For example, in the production of penicillin, a lot of nutrients need to be added in the process of cultivating penicillium, which will inevitably introduce a lot of impurities, and a way must be found to separate impurities. However, it is nearly impossible to get rid of all the impurities in drugs.

Generic drugs and original drugs, which to choose?

It can be seen from above that although the price of generic drugs is lower, which can reduce the financial burden of patients, they cannot be exactly the same as the original drugs. Individualized choices need to be made, and the pros and cons of price and curative effect must be fully weighed. Generally, for patients who are clinically considered special, such as elderly patients, children, women, pregnant women, etc., higher-quality drugs or the original drugs are recommended.