First line clinicians worry that generic drugs are still difficult to compete with the original drugs

Source: e-medicine Facebook 2016-12-08 based on the current situation of generic drugs in China, the original drug is still the best choice for the clinical front line Is there a big difference between the efficacy of the original research drug and the generic drug? Recently, at a media conference of the State Food and drug administration, a doctor from a large top three hospital expressed his concern about domestic generic drugs and his expectation for the reform of the current drug review and approval system As a first-line clinical doctor, although he will not give tendentious recommendations on the choice of drugs to patients But objectively speaking, the original drug is still the best choice Because once the disease worsens, there is no regret medicine for life In the early stage of reform and opening up to improve the standard of drug use in precision medicine, the national living water products are still in a relatively "shy" stage Even if some young people have outstanding talents, they may have to make a second choice because of family reasons The development of medicine in China is just like the reform of patients' access to medical care, which is dominated by policies and its own conditions The policy determines the general direction of medical development, but the cost of medical treatment determines the level of basic medical treatment In January 2015, President Obama of the United States put forward the plan of precision medicine during his state of the Union address In the following March 2015, the Ministry of science and technology also held the first expert meeting on precision medicine strategy in China and put forward China's precision medicine plan Since last year, precision medicine has been discussed in every occasion involving medicine But what exactly is precision? In the era of relatively backward medicine, cancer is basically the declaration of death The patient who appears in front of the doctor at this moment may not be able to see him again because of his short life span However, at present, cancer is gradually treated as a chronic disease Under the control of drugs, the survival period of patients is prolonged as much as possible In fact, the price of the original drugs for cancer treatment is generally high, and the monthly treatment cost of tens of thousands of yuan is hard for ordinary people to bear Even if there are ways to use drugs free of charge, such as by being a clinical trial object of drugs or participating in charity drug donation programs, not all patients are lucky enough, and the risks are self-evident Therefore, many patients can only give up treatment in the end However, generic drugs have been facing the situation of "color change" An expert involved in the drafting of the 12th Five Year Plan for national drug safety once said publicly: "only one tablet is needed for the original research drug, but five tablets are needed in China." However, this does not mean that the short board of generic drugs only exists in the lower pharmaceutical process standards in China In the United States, the generic drugs that can be approved by FDA must have the same active ingredients as the products to be imitated, and have the same indications, dosage forms, specifications and routes of administration as the products to be imitated At the same time, the bioequivalence and quality must meet the same requirements However, for many years, Chinese pharmaceutical manufacturers have maintained the status quo of insufficient R & D investment and weak innovation ability Compared with developed countries, some generic drugs have a large gap On the one hand, China's drug review and approval only pays attention to the control of "quality standards", while in the aspect of bioequivalence verification, it is laissez faire Although the lack of medicine in the pharmaceutical industry blank period, generic medicine has saved many people's lives However, driven by the market interest and the huge gap in pharmaceutical technology, most of the generic drugs have the same chemical composition as the original drugs, but the clinical effectiveness cannot be guaranteed, and even some of the clinical data of generic drugs have the problem of counterfeiting In the world, the "qualified invalid drugs" produced in China are basically not recognized, and a large amount of medical expenditure is wasted in exchange for the "placebo" produced and sold by ourselves In particular, a series of personnel "earthquakes" in drug administration ten years ago made the "gap" of domestic generic drugs invisible in full view of the public During his tenure, Zheng Xiaoyu, the former director of the State Food and drug administration, approved without authorization to reduce the approval standard for the renewal of drug production number in the nationwide unified work Drug companies hire officials and experts as consultants to give huge commissions, and the price of an approval can reach tens of millions, resulting in many drugs that should not be changed or revoked the approval number to obtain the number, and six of the approved more than 10000 drugs are fake drugs On the other hand, although some high-quality domestic generic drugs have achieved remarkable results, they are not far behind the imported original research drugs in terms of price Some of them are only 2000 to 3000 yuan less, and even more expensive than the original research drugs And that's why many patients, with or without health care, will still try to buy Indian generic drugs - the treatment cost gap is dozens of times per month, and the curative effect may be better than domestic generic drugs At present, the development trend of cancer diseases in China is still not optimistic According to the data of China Cancer Registration Center 2015, six people are diagnosed as malignant tumors and five people die of cancer every minute in China Such a high base reflects the urgent medical needs of patients and the huge gap in cancer treatment in China In the face of such a rigid demand, the original research drug and excellent imitated pharmacology should obtain the qualification of priority review and speed up the review, and the sequela of "qualified and invalid" imitated drugs must be cured at the same time Opinions on the evaluation of quality and efficacy consistency of generic drugs issued by the general office of the State Council was officially released in March, requiring pharmaceutical enterprises to evaluate the consistency of quality and efficacy between generic drugs and original research drugs For generic drugs approved for marketing before the implementation of the new registration and classification of chemicals, if they are not approved in accordance with the principle of consistency with the quality and efficacy of the original drugs, the consistency evaluation shall be carried out For the chemical generic oral solid preparations approved for marketing before October 1, 2007 in the national essential drugs catalogue (2012 Edition), the consistency evaluation shall be completed by the end of 2018, among which the clinical effectiveness test and the varieties with special circumstances shall be completed before the end of 2021, and those that are not completed within the time limit shall not be registered again In fact, up to now, many enterprises have not started the evaluation In a lament, most pharmaceutical companies are struggling with "no money" and "no one" But for the domestic generic drugs that have not experienced the big test, consistency evaluation is the only way, and also a way to make up lessons The government has given drugs low threshold for a long time, and the consistency evaluation is a good opportunity for domestic generic drugs to redeem themselves under the continuous growth of the market At the same time, it will also promote the healthy development of related industries such as cro