First of all, as a pharmacy graduate, I have worked in both original and generic drug companies, and now I mainly work on generic drugs. Those who have participated in the implementation of new product planning projects of foreign generic drug companies said that they respect the original research companies of original drugs.
R&D is great, R&D is expensive, and R&D is easy to fail, so I understand that their prices are high. If you want to jump for this reason, please go out and turn left first.
However, I have also heard directly from the research and development of foreign original research companies that their profit margin must be at least 90% or more, otherwise they will not be able to survive the subsequent clinical costs, adverse reaction reporting costs, patent expiration costs, and many other costs, etc. Therefore, the real commercialized new drugs are really developed by no one for charity, and this in itself is understandable. But on the other hand, the commercialized new medicine is that there is no white lotus in the business, and there is never a need for the gesture of "I have contributed to mankind, why do you still ask for so much".
The reason for writing this is mainly to see another voice from friends who have watched the movie, "Why can't China make such cheap and high-quality generic drugs made in India"?
Much of India's attitude towards drug patents has been popularized. If you think that China cannot create it, you can't blame the masses. It can only be said that the public accounts have not really promoted the idea.
First of all, the idea of "can't make it" is more derived from "can't see it in the market". On the one hand, the patents involving Tianchao still have a period of protection, which is why China's imatinib mesylate (the raw material drug name of Gleevec) was only launched in 2013 and 2014. China and India, as two large bases for generic drugs (production and export to the world), have excellent research and development capabilities and selection capabilities. When I knew the generic drug company in the third clinical phase of the excellent new drug variety abroad (science popularization, the clinical phase is divided into four phases, the drug has not been officially launched in the third clinical phase), and the process research and development of this variety has been completed. In a country where the approval time is normal and predictable [not in the Black Administration], imagine that the patent of a product expired in 2012, then the preparation company should push the research and development backward, and the raw material drug supplier should be screened, and the application approval time may start in 2008. Looking for manufacturers of raw materials. As for the manufacturers of APIs, the production process may have been developed two or three years ago. So in 2002, was the Chinese Dynasty really without "Gleevec"? On the other hand, it also involves a relatively long time for the approval of the General Administration. If the generic drugs produced by the Celestial Dynasty were bought in China at that time, it would really be a "fake drug" at the gunpoint.
In addition, there will be debates not only in China but also in various countries about whether generic drugs are equivalent to original drugs. At this time, there needs to be a keyword called "consistency evaluation" [please Baidu], which is simply to prove that the generic drug is equivalent to the original research.
In the past, Chinese companies did not do this, which undoubtedly reduced the difficulty and investment of generic drug companies in applying for approval, that is, lowering the threshold for generic drug companies to enter the market. Interested friends can understand that the Food and Drug Administration [now no longer exists, changed its name and changed its jurisdiction] has made great strides in recent years. It has launched a series of policies mainly to speed up the approval process, such as generic drug companies. Do consistency evaluation (a variety will probably cost several million yuan), such as verification of production process and registration process (that is, to check whether the actual production process and registration documents are consistent), such as the verification of clinical data, recently, due to the official joining of ICH by China [Background: ICH is the three poles of Europe, America and Japan, which basically represent the most advanced and standardized drug-related specifications], China is making every effort to strengthen the production and circulation supervision of drugs, which also directly promotes the overall quality of China's drugs.
Returning to the topic of imatinib mesylate, the currently approved preparations include the original researcher Novartis, CSPC Ouyi [preparation exporter] and Jiangsu Haosen [preparation exporter], these two can be said to be excellent domestically Representatives of pharmaceutical companies. In addition to searching the database, dozens of companies are applying for approval at the same time, and they are basically all outstanding companies. Among them, Jiangsu Haosen has officially passed the consistency evaluation, which can be said to be a very good news.
Of course, as to whether the original research and imitation can be 100% equivalent, and whether there will be any problems after eating the original research and replacing the imitation, I have always believed that in addition to the drug itself, taking medicine is also related to the situation of the human "receptor" (such as clinical Placebo), please follow the doctor's advice.
It is even more unnecessary to blindly believe that "the Chinese dynasty cannot make good medicine". In addition to the emerging new drug research and development varieties, the preparations are exported to Europe, America and Japan, and they are used for the entrusted production and processing of intermediate and API preparations for top new drug companies (for example, this Nova, how many varieties are actually made by themselves, and how many outsourced production projects are outsourced). Companies that have received generic drug approvals from the U.S. FDA continue to emerge in large numbers. The efforts of Chinese pharmaceutical companies are the same as those of Chinese people in other industries. The last thing they should do at this time is to "underestimate oneself".
Finally, it's about the future of generics.
To reiterate that the original research drug is great, but unfortunately for the original research drug, for most of the national generic drugs is the real future for the implementation of mature varieties ZF. Of course, I have to admit that there are strong economic considerations and ZZ significance.
For example, in our neighboring country, Japan, which is seriously aging, ZF is fully promoting generic drugs and even put forward the policy of having an 80% market share for generic drugs in the future. Not only Japan, many countries are also fully implementing generic drugs. On the other hand, even if the cost of research and development is greatly reduced, generic drug companies will not necessarily live well. During the current drastic changes in Chinese policies, it is naturally easy for companies that are at the forefront of laws and regulations to break out of the Warring States Period. However, after the laws and regulations are truly mature, they may learn from the situation of neighboring Japan again, and they may find themselves in the patent of a big new drug. After the expiry date, 30 generic drug companies with the same active ingredient were listed on the same day at the same time.
New drug companies are great. Of course, no one can deny the huge profits of new drug companies. You can also see news that Trump or Abe asks pharmaceutical companies or blockbuster new drugs to cut prices. It is never a bad thing to force the original researcher to lower the price through the competition of generic drug companies.
So what is the road, "new drugs + generic drugs" must be the most appropriate. The high cost of research and development of new drugs, high prices to solve chronic diseases and promote human health, and generic drugs allow the general public to take better medicines. The policies of many countries have proved this problem. For enterprises, more and more new drug-type companies have begun to introduce generic drug departments and products. After all, even Novartis owns "Sandoz", which specializes in generic drug business.
In the end, I personally feel that the film's understanding of medicine is basically on the point.
Very, very, very hope that this movie is the fire of a prairie fire, and now it has lit up public opinion. I hope that public opinion can really do something in the future, at least let Gleevec really fully enter the medical insurance, that is also a very great thing .
Finally, I wish everyone good health. Just sauce.
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