Call for "multi-party joint efforts" to make consistency evaluation products truly replace the original research!


Time:

2018-08-06

With the normalization and institutionalization of generic drug consistency evaluation, the enthusiasm of domestic pharmaceutical companies will be further released. This will play a positive role in the development and production of generic drugs, as well as allowing patients to use cheap and high-quality drugs. Recently, the State Drug Administration issued an announcement announcing that 16 varieties of 11 pharmaceutical companies have passed the consistency evaluation of generic drug quality and efficacy, which is also the fifth batch of lists that have passed the consistency evaluation. It is worth mentioning that the announcement shows that this will be the last batch announcement of the State Food and Drug Administration through the consistency evaluation of varieties. In order to further improve work efficiency, it has since passed the generic drug consistency assessment.

With the normalization and institutionalization of generic drug consistency evaluation, the enthusiasm of domestic pharmaceutical companies will be further released. This will play a positive role in the development and production of generic drugs, as well as allowing patients to use cheap and high-quality drugs.

Recently, the State Drug Administration issued an announcement announcing that 16 varieties of 11 pharmaceutical companies have passed the consistency evaluation of generic drug quality and efficacy. This is also the fifth batch of lists that have passed the consistency evaluation.

It is worth mentioning that the announcement shows that this will be the last batch announcement of the State Food and Drug Administration through the consistency evaluation of varieties. In order to further improve work efficiency, the varieties that have passed the consistency evaluation of generic drugs will be included in the "China Listed Drug Catalogue" in a timely manner for real-time inspection by the industry, the public and relevant departments, and will not be announced in batches. Some insiders pointed out that with the normalization and institutionalization of generic drug consistency evaluation, the enthusiasm of domestic pharmaceutical enterprises will be further released. This will play a positive role in the development and production of generic drugs, as well as allowing patients to use cheap and high-quality drugs.

Change "Big but Not Strong" to Achieve "Medical Treatment for Diseases"

Previously, 41 varieties had passed the consistency evaluation of generic drugs, plus 16 varieties this time. Since the end of 2017, a total of 57 varieties of drugs have passed the consistency evaluation.

Because of the long research and development cycle, large investment and high price of the original research drug, the cost-effective and more accessible generic drugs are widely encouraged in the world. Generic drugs have the same active ingredients, dosage forms, routes of administration and therapeutic effects as the original drugs. They have important economic and social benefits such as reducing medical expenditures and improving drug accessibility. They are also an important guarantee for achieving "medical treatment for diseases.

However, although there are many generic drug companies in China, "big but not strong" has always been a portrayal of the generic drug industry. Due to the large difference in drug quality, China's high-quality drug market is mainly occupied by high-priced foreign original research drugs, high-quality, cheap generic drugs are hard to find.

Since 2015, China has started the consistency evaluation of generic drugs. For generic drugs that have been approved for marketing, the quality consistency evaluation will be carried out in stages and batches according to the principle of consistency with the quality and efficacy of the original drugs. The quality and efficacy of generic drugs must reach the level consistent with the original drugs.

Lai Shiqing, Inspector of the System Reform Department of the National Health Commission, said that the purpose of imitation is to replace it. Confidence in domestic generic drugs should be established in many ways. Experts said that by promoting the consistency evaluation of generic drugs, gradually expanding the market scale of generic drugs, creating a good development environment for them, allowing generic drugs to compete more fully with innovative drugs, and driving the price of innovative drugs back to the level of generic drugs, it is a feasible way to reduce drug prices.

It is not easy to pass the consistency evaluation. To produce drugs that are comparable to the original research technology and quality, pharmaceutical companies need to have certain financial and technical strength. In the previous consistency evaluation, many well-known pharmaceutical companies of generic drugs "failed".

In April this year, the General Office of the State Council issued the Opinions on Reforming and Improving the Supply Guarantee and Use Policy of Generic Drugs. Opinions put forward to improve the quality and efficacy of generic drugs, accelerate the evaluation of the quality and efficacy of generic drugs, improve the quality of pharmaceutical raw materials and packaging materials, improve the level of process manufacturing, and strengthen drug quality supervision. Experts pointed out that this has set up a "benchmark" for improving the quality standards of generic drugs ".

Pharmaceutical companies "speed up" to accelerate the "survival of the fittest"

With the advancement of consistency evaluation, the pattern of China's generic drug industry has also ushered in many changes. In addition to the strict requirements on quality and efficacy, the "time window" also means that pharmaceutical companies must "speed up".

According to the requirements, the consistency evaluation must be completed by the end of 2018 for the varieties of oral solid preparations of generic chemical drugs in the national essential drug list approved for marketing before October 2007, and those who fail will directly cancel the drug approval number. The reporter found that of the 16 varieties that passed the generic drug consistency evaluation, 5 varieties belonged to the variety catalog (289 catalog). As the deadline approaches, many drugs are at risk of being phased out.

In addition, according to regulations, after the first three companies of the same variety of drugs pass the consistency evaluation, they will no longer approve other consistency evaluation varieties after 3 years. This means that if they cannot break into the "top three", the relevant pharmaceutical companies will lose the market for the drug. Up to now, rosuvastatin calcium tablets, montmorillonite powder and other drugs have been "full", and there are nearly 10 varieties with only one quota left. Some people in the industry pointed out that the consistency evaluation will make about 60% of China's generic drug approvals withdraw from the market, which is also a "big test" for pharmaceutical enterprises ". It is of great significance to promote the supply-side structural reform of the pharmaceutical industry and realize the leap from a pharmaceutical power to a pharmaceutical power in China. With the gradual normalization and institutionalization of consistency evaluation, the initiative and enthusiasm of pharmaceutical enterprises will be further enhanced, and the trend of "survival of the fittest" will gradually appear.

If you want to "take root on the ground", you need to rely on "multi-party efforts"

On the basis of improving the quality and efficiency of generic drugs, how to make the market accept and let generic drugs "take root on the ground" has become a more urgent issue. Experts said that it is necessary to speed up the promotion of terminal use, so that doctors are willing to prescribe prescriptions and patients are willing to use them, so that high-quality generic drugs can be used and used well.

According to the previous opinion requirements, generic drugs that pass the consistency evaluation will receive preferential treatment and support in terms of bidding procurement, drug pricing, medical insurance payment and industrial funds, and medical institutions should give priority to procurement and clinical selection. At the same time, we will speed up the formulation of payment standards for medical insurance drugs, pay generic drugs and original research drugs that are consistent with the quality and efficacy of the original research drugs according to the same standards, and implement preferential tax policies and price policies.

In response, Fu Hongpeng, a researcher at the Health Development Research Center of the National Health Commission, said that the linkage to open up procurement, medical insurance, clinical use and other links will promote equal competition between generic drugs with consistent quality and efficacy and original research drugs, and break the high-priced monopoly of patented original research drugs on the drug market. The implementation of the policy of alternative use of generic drugs will increase the enthusiasm of generic drug companies to participate in consistency evaluation, and form a virtuous circle of drug quality and efficiency.

In order to support the development of generic drugs, various places have launched a good. According to statistics, up to now, more than 10 provinces and cities have issued relevant supporting policies to ensure that drugs that have passed the consistency evaluation enter the online procurement catalog. On the one hand, to promote fair competition between generic drugs and original research drugs. For example, Hubei has opened up a "green channel" for high-quality generic drugs to promote the rapid entry of drugs that have passed the consistency evaluation into hospitals. Zhejiang stipulates that medical institutions can temporarily break through the "one product, two regulations" in the "Prescription Management Measures" before the end of 2018, and increase the purchase and use of products that have passed the consistency evaluation. In terms of price, "price limit" is a clear requirement of many provinces, and many provinces also require "national minimum price". Under the impact of high-quality and low-cost generic drugs, many foreign original research drugs have recently opened a "fast channel" of price reduction and volume ".

Although the "harvest period" for generic drug consistency evaluation has begun, it will take a concerted effort to truly replace the original drug and reduce the price of the drug. Shi Lu Wen, director of the Department of Pharmacy Management and Clinical Pharmacy of the School of Pharmacy of Peking University, pointed out that in order to really make generic drugs work, the following policies are needed. From bidding, procurement to medical insurance reimbursement and entering hospitals, all links need to build corresponding supporting mechanisms.