117 varieties do not require consistency evaluation! How does China's generic drugs break the ice?

Guide: From the development of generic drugs in the United States to see the consistency evaluation of Chinese generic drugs! Recently, the Drug Review Center of the State Drug Administration issued the "Clinical value is clear, can not recommend reference preparations of the chemical drug catalog (first batch)," 117 varieties do not need to carry out a consistent evaluation, there are 40 injections, 25 tablets, 3 dispersants, 4 particles, 4 capsules, including mentaminine potassium magnesium injection, conversion of glycolytic electrolyte injections, aluminum magnesium and chewing tablets.
, however, at present, the national collection has gradually become normal, generic pharmaceutical companies to promote consistent evaluation is imperative, otherwise not only lose the market, but also directly eliminated out.
based on the author's many years of experience in medicine, want to spy from the development of generic drugs in the United States, China's generic drug consistency evaluation of sustainable development.
the U.S. generics division, where is the difference between Chinese generics? China's pharmaceutical industry is weak, like a baby, light, heavy, early medical reform is like itching boots, can not achieve significant results.
, China's national pharmaceutical companies on the generic drug market, the rush, and even more boss "take a pat", a generic drug on the market.
and lack of regulation is also a cause of the proliferation of generic drugs, low-level repeated construction is a major feature of early generic drugs.
, the State Drug Administration received 10,009 applications for "new drugs" in 2004, compared with 148 in the same period.
2005, the Drug Administration approved 11,086 applications for drug registration, 80 per cent of which were generics.
data show that China's more than 5000 pharmaceutical companies, 99% are generic pharmaceutical enterprises, drug approvals as many as 190,000, 95% are generic drugs.
of China's pharmaceutical enterprises are mainly generic drugs, in 2018 in the domestic market, generic drugs accounted for 63%, the rest of the innovative drugs 3%.
1. Poor in the accessories of China's pharmaceutical industry colleagues general consensus, China's part of the quality of generic drugs and the international advanced level there is a large gap, a large part of which is due to the problem of accessories.
drug is not a single ingredient, the effect of accessories on drug efficacy and safety is also greater.
products because of the influence of accessories, resulting in an increase in adverse reactions, in foreign countries have withdrawn from the market.
U.S. Food and Drug Administration requires generic companies to declare pharmaceutical accessories, as well as GMP certificates and laboratory analysis certificates for accessories manufacturers, and provide analytical steps.
there are no mandatory specifications related to accessories, the quality of accessories is not the same, affecting the efficacy and safety of drugs.
2. Poor in the quality standards of Europe and the United States, the imitation of drugs biological equivalent testing of the drug must be the end of the patent protection period of the original drug, China allows imitation of the listed domestic generic drugs, resulting in the lower the bio-use, the worse the effect of the drug, which will be improved in the new consistency evaluation.
past, technical review standards were too low, the power of generic drug approval was concentrated, and it was difficult for the public to obtain the right to know, making it difficult for domestic pharmaceutical companies to declare success without rigorous research, especially behind the scenes.
, some generic drugs in China can now do only chemical equivalents, and generic consistent evaluation promotes biological equivalents, safety equivalents.
, learning from the United States, the brother of the big innovative drug nations, is also a powerful way to develop rapidly.
the path of imitation in the United States, the chinese characteristics of medicine in 1983, only 35% of the best-selling original drugs with expired patents face competition from generic drugs, and generics market share is only 13%.
the reform of the early generic drug system to guarantee the development of generic drugs, resulting in many original drugs facing competition for generic drugs.
early policies led to the first imitation to obtain a separate pricing power, but also to seize the market opportunity to gain a majority of market share, so many generic drug companies compete to "grab imitation."
and the FDA's "first come, first until" offer plenty of room for approval, and drug companies are bribing reviewers in a well-known "generic drug scandal" in U.S. history.
1984, Bolar Pharmaceuticals issued 40 ANDA applications to ensure the product's first qualification, and a later investigation found that most of its applications were fraudulent.
, the United States went through the process of biological equivalents and alternatives to the original drug, that is, through a certain biological equivalent study, to confirm that the efficacy and safety of generic drugs and the original drug is equal, by doctors to prescribe branded drugs or generic drugs, by the pharmacist to decide which generic drug to replace, such a process to help the United States prescription drug use, from innovative drugs to the original drug transformation.
But the process didn't go well, and in the early years, some original drug companies launched a powerful offensive to discredit generics and throw out complaints about alternatives as part of an offensive to discredit generics companies.
in some special areas, attacks by foreign companies are working, and the rate of seizures in patients is decreasing and is being recognized by patients as a result of their offer to switch back to the original drug.
2011, generics accounted for 80 percent of prescriptions and 27 percent of total drug sales of $320 billion.
total U.S. drug spending in 2018 was $344 billion, while the overall generic formulation ratio increased from 75 percent in 2009 to 90 percent in 2018.
the rapid development of generic drugs in the United States, thanks to its reform of the generic drug system, but also have results and lessons, worthy of our reference.
under the pressure of the collection, the development mode of generic drugs changed, how to break the situation? At the end of 2018, CDE pointed out that generic drugs listed before the implementation of the new registration classification of chemical drugs, which have not been approved in accordance with the principle of consensus, must be evaluated, involving more than 100,000 symbols, more than 4000 varieties.
From the development path of generic drugs in the United States, once through bioethic and alternative processes to help its rapid development of generic drugs, China's generic drug consistency started late, but with the national collection policy, generic drug development model changes, the trend is fierce, its significance is far-reaching.
1. Improve the quality through the evaluation of the consistency of generic drugs, China's generic drugs in the quality and efficacy will be greatly improved.
from the present point of view, most of the consistent evaluation of generic drugs into the national collection, will promote its dosing, and ultimately form the scale effect of the use of generic drugs, for its enterprises and product brands to lay a good foundation.
But like the United States, some foreign pharmaceutical companies still propose that "bioethics" are different from "clinical equivalents" and amplify the concept of original drugs to influence prescription doctors, which has achieved its goal of continuing to occupy market share.
2. Reducing the consistent evaluation of generic drugs can reduce the cost of generic drugs for patients, through consistent evaluation of generic drugs, in terms of quality and the original research drug consistent, because generic drugs into the study cycle is short, research costs are not as high as the original drug, so the price is often much lower than the original drug, if the clinical drug priority can be replaced by generic drugs, can greatly reduce the cost of patients.
especially at home, in addition to its own low drug development costs, the price of generic drugs is low, coupled with the collection of chinese generic drug prices with global competitiveness.
3. Industrial upgrading this is the best, a large number of generic drug companies can not survive through generic drug development, forcing generic drug enterprises to transform, while promoting the survival of China's pharmaceutical companies, many pharmaceutical companies in order to obtain more competitiveness has been strengthening new drug research.
the transformation of traditional pharmaceutical companies will be completed in recent years, innovation or imitation will be an option.
China's generic drug model reform road is rugged, but with reference to the development of the United States, it seems that China's generic drug development model is beginning to appear, this process is bound to be mixed with the game of all parties, there are winners, there must be the losing party.
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