Hearing the word GM, I believe many people will have questions. Is this fake and shoddy medicine? This view is really one-sided. Generic drugs are not fake and shoddy drugs. Like the "original drug", they have to go through layers of examination and approval. They are conventional drugs recognized by law.
Let's start with the original research drugs and generic drugs in our country. The Measures for the Administration of Drug Registration, revised on July 10, 2007, put forward higher requirements for the research, development, application and production of generic drugs, especially pointing out that generic drugs should be consistent with the original drugs in terms of safety, effectiveness and quality. At the beginning of 20 12, the Notice on Printing and Distributing the Twelfth Five-Year Plan for National Drug Safety also mentioned that the quality of generic drugs should be improved in an all-round way.
It can be seen that the state attaches great importance to the original research drugs and imitation drugs.
So, what is the difference between the original drug and the generic drug?
Before you say the difference, you must look at the definition of the two.
What does the original medicine mean? You can tell from the name that it is the original drug. It can also be called a patented drug. Generally, large pharmaceutical companies independently research and develop. Clinical trials are very strict, and then they have to go through examination, approval and registration before they can be listed.
Relevant data show that it takes about 10- 15 years from research and development to market, and the cost can reach hundreds of millions of dollars. This drug has an obvious feature: it cannot be copied before the patent expires, and it is also protected by relevant policies such as independent pricing, so its efficacy and safety are guaranteed to the greatest extent.
What do you mean by generic drugs? Literally, it means imitating artificial drugs. Once the original drug has passed the patent protection period, other enterprises can copy it. Generic drugs are imitations of the main components of the original drug. Its production cycle and research and development cost are much smaller than the original drug, and its price is also lower than the original drug.
Due to the advantages of short cycle, low cost, quick response and low price, the share of generic drugs in China has reached 98%.
Have you ever heard a proverb? The original drug gives hope to patients, and the generic drug gives patients the possibility. This sentence actually shows that there are similarities and differences between the two.
There are five main points about their similarity: including the same active ingredients (main ingredients); The same route of administration; The same dosage form; Same specifications; The same therapeutic purpose.
This answer is mainly about the difference between the two, which is still obvious.
1, the price is different.
However, I said that everyone must know that the original drug is expensive and the generic drug is relatively low. This mainly includes explicit costs and implicit costs. Explicit costs include raw material costs, packaging shapes, etc. Invisible costs include clinical trials, intellectual property rights, production costs, research and development, etc. Generally speaking, the hidden cost accounts for a large proportion of the cost of the original drug, while the cost of generic drugs is mainly the explicit cost, so the price is cheaper than the original drug. Therefore, we can also see a phenomenon that generic drugs are widely used in clinic in our country instead of original drugs.
2. Different research and development.
The research and development of the original drug is extremely complicated and costs a lot of money. The first stage is the early detection stage, and the time and cost will change at any time; The second stage is the stage of discovery and development. It takes about 5-6 years to screen out 10 compounds from tens of millions of compounds, and the cost of the first and second stages accounts for 30% of the total cost. The third stage is the clinical trial stage, which is divided into stages I, II and III, and the average trial time is about 7 years. The fourth stage is the approval stage. A compound takes about 1.5 years, and the cost of the third and fourth stages accounts for 70% of the total cost.
According to statistics, it takes an average of 10- 15 years to study 4000-5000 chemical structures, and the investment is 300-500 million dollars.
Compared with the original drug, the cost of generic drugs is much smaller. The most obvious thing is time, about 3-5 years. Generic drugs have low cost, short cycle and low risk. Regarding generic drugs, at present, the country requires that bioequivalence research must be done, but large-scale clinical trials are not needed.
3, the quality is different
Different ingredient contents: According to clinical experience, different ingredients contents of different brands (original drug and generic drug) of the same drug will lead to different curative effects.
Impurities and residues: mainly the purity of raw materials, which affects the content and stability of effective components in drugs.
Packaging materials: Different packaging materials will cause the migration and adsorption of effective components of drugs, resulting in different efficacy, and side effects are also possible.
4, the process is different
There are differences and gaps in the production technology of the two kinds of drugs, which leads to differences between batches and even between bottles, resulting in obvious differences in quality and efficacy. On the premise of meeting the standard, the impurity degree of the product depends on the process. If the impurities exceed the standard, we must work hard on the process.
Process level is the key to shorten the gap between generic drugs and original drugs.
5, security issues
In terms of inspection and testing, the original research time is definitely longer than that of generic drugs. Everyone should know why drugs need to be tested, that is, to test their efficacy and safety. Generic drugs don't need mechanical energy phase II, III and IV clinical trials, so they lack a lot of clinical data, so they can't accurately evaluate their actual effects and fully confirm their actual performance.
As you may know, our country is a big country of generic drugs, but the quality and standards need to be improved. Due to the overall economic level, there is still a gap between domestic drug quality standards and international standards in terms of technical level, research and development. Of course, if the relevant data of this generic drug is very good, it is basically no problem to replace the original drug. However, for drugs without clinical data, generic drugs are not necessarily suitable, and it is definitely safer to use the original drug.
It is hoped that medical workers will make joint efforts to shorten the gap between generic drugs and original drugs in China, so as to make people healthy and the country blessed.