Compete for the volume of purchase tickets, the consistency evaluation of drug injections opening drama.

, the State Drug Administration issued the "Announcement on the evaluation of the quality and efficacy of generic chemical injections" (No. 62 of 2020). The announcement noted that generic chemical injections that have been listed are subject to consistency evaluation for varieties that have not been approved in accordance with the principle of consistency with the quality and efficacy of the drugs in the original study. On the same day, the National Drug Review Center issued three documents, "Technical Requirements for the Evaluation of The Quality and Consistency of Chemical InjectionS" and "Requirements for the Evaluation of The Quality and Efficacy Of Chemical Injections" and "Technical Requirements for evaluation of the Quality and Efficacy Consistency of Chemical Injections (Special Injections) Generic Drug Use." This marks the "warm-up" of the long-term chemical injection consistency evaluation officially opened the overall promotion of the curtain.
industry insiders said that with the continuous in-depth promotion of the volume of procurement, the consistency evaluation of chemical injection injections will soon usher in the climax, the future of this market is bound to be divided. For head enterprises, more financial, material and energy can be invested in expanding production and meeting higher standards, while some small and medium-sized pharmaceutical companies may be forced to face survival and transformation problems. In addition, it is not good to focus solely on the varieties of consistency evaluation, pharmaceutical companies should also increase innovation efforts, and simply focus on the policy within the market is also not good, but also to consider how to lay out the policy outside the market, and even to the large health sector cross-border transformation.
Pharmaceutical Observer: Since 2016, when the General Office of the State Council issued the Opinions on the Evaluation of The Quality and Efficacy of Generic Drugs, there has been no "big action" in the injection of chemical drugs. Are the conditions now ripe?
Shi Lichen: Compared with oral solid preparations, injection consistency evaluation is more difficult, the requirements are relatively high, the standard process of the entire BE test, key nodes, as well as reference preparations, etc. have a lot of grasp. Moreover, generic consistency evaluation is the first time in China to do, whether the approval department or pharmaceutical companies, are not familiar with, so from the relatively simple oral solid formulation to start. Now accumulated a lot of experience, and then do difficult, demanding injection consistency evaluation, it is easier.
the current conditions can be said to be mature, but not fully mature, mainly because the country wants to improve the quality of medicines as soon as possible. Now health insurance pays for a lot of ineffective drugs, so forced, helpless, and must do the same evaluation of injections. But now there is still a problem that remains unresolved, that is, there are too few clinical institutions qualified to do BE trials, only more than 600. This can result in higher costs and longer cycles. Qi Zhengwei,
: The policy for the evaluation of generic consistency has adopted the strategy of oral solid preparation and then injection preparation, the focus of the two is different, the former focus on improving the quality and effectiveness of drugs, the latter on safety. Prior to the injection to carry out consistency evaluation there are some technical difficulties, such as the selection of reference preparation stylistic principles, raw materials problems, package materials, as well as three changes (change specifications, change the form, salt change), etc. , there are complex aspects. With the publication of the catalogue of injectable reference preparations and the item-by-item solution of the above-mentioned problems, the conditions for the consistent evaluation of the injection preparations have been basically mature.
Guo Xinfeng: The slow progress of injection consistency evaluation lies in: 1. Weak technology, such as impurity research is unusually complex, some accessories are not easy to obtain, the material requirements are high, the domestic supply is insufficient, research and development technology level needs to accumulate. 2. Insufficient talent reserve, because injections for high-risk high-barrier products, foreign new drug development preferred dosage form is often oral preparations, adhering to the "can orally do not inject, injection of a needle equivalent to a small surgery" concept, injection can not be preferred use, which results in foreign injection production and development of relatively concentrated monopoly, talent scarcity. China's drug regulatory departments in 2017, 2019 and January 2020 for the injection consistency evaluation for consultation, it should be said that the preparation is fully prepared, with the start-up conditions.
Tu Honggang: The consistency evaluation of chemical injections has not seen any progress so far, and it is related to its difficulty and high safety requirements. The main difficulty of the evaluation of injection consistency lies in the determination of the selection of reference preparations, the contents and standards of the research projects, and the technical affordability of Chinese injecting drug enterprises. Most importantly, regulators also need to find out whether the results of the current consistency evaluation of injections produced by Chinese enterprises are controllable, because injections are more stringent in the requirements of aseptic assurance, compatibility, sealing, etc. In addition, a large number of manufacturers of core profits from injections, once included in the collection of profit margins will be seriously reduced, the damage is far more than the benefits, so on the sidelines, as far as possible to delay progress.
pharmaceutical observers: oral solid preparations to carry out consistency evaluation at the beginning, the attitude of enterprises are not the same, some positive response, and some take a wait-and-see attitude. By summing up the lessons learned, there will be injection enterprises there is a wait-and-see, or even ready to give up the mentality?
Tu Honggang: After experiencing the consistency evaluation of oral solid preparations, many enterprises began to plan ahead, especially large varieties of pharmaceutical companies, has been laid out in advance. Because consistency evaluation is a good time to reshape the market pattern, do it quickly and well done, it may stand out in similar products! According to the experience of Japan and the United States, each variety to do consistency evaluation, is a shuffle process. From these two aspects, most of the large-scale pharmaceutical companies are still positive. Data show that as of May 18, the total number of acceptance numbers for injection consistency evaluation scored 771. There have been 44 standards/27 varieties treated as if they had passed the consistency evaluation. At present, a total of 163 enterprises of injection consistency evaluation varieties into the acceptance stage, the largest number of acceptance is Qilu Pharmaceuticals, a total of 29, followed by Yangzijiang, reached 28, Sichuan Koren Pharmaceuticals ranked third, 26.
Guo Xinfeng: China's generic drug market injection stake is high, the use of large, especially in-patient patients, the probability of injection use is large, which for pharmaceutical companies, it means that the injection market capacity is large, the temptation is large. From the current collection policy, the National Health Insurance Bureau is responsible for evaluating generic drugs for national collection, provincial health insurance bureau is responsible for the non-evaluation of generic drugs for provincial-level procurement, which will divide injection enterprises consistent evaluation strategy, in the end is to spend millions of dollars long-distance running 2 years to grab the national harvest dividend, divide the national market, or low-cost first to grab the actual dividend of the province-belt procurement? Different pharmaceutical companies have different options.
Shi Lichen: Now is not a wait-and-see issue, like Beijing with volume procurement on the clear, no evaluation of the drug hospital is not allowed to buy. In the future, into the policy market, consistency evaluation is a hard indicator, must be done. Of course, there may be some enterprises do not care, such as amendments, Jiangzhong Pharmaceuticals, etc. , they are to pharmacies and other out-of-policy markets, and there are few varieties of injections. In addition, injections are mostly in the hands of large enterprises, large enterprises do not have a wait-and-see problem, will rush to do. The remaining small and medium-sized enterprises, if the product lacks competitive advantage, then simply give up, pain quickly relief.
Qi Zhengwei: After the practice of oral solid preparation consistency evaluation in recent years, especially from the "4 plus 7" band procurement pilot to expand capacity, expansion of the scope, the production enterprises have been completely clear that the future generic drugs also want to be sold in Chinese hospital channels, the volume of procurement is the threshold, and through consistency evaluation is a necessary condition, therefore, injection enterprises should be more active to participate in the consistency evaluation work, unless they want to give up their injection products.
Pharmaceutical Observer: According to the policy requirements, chemical injections since the first variety through the consistency evaluation, other pharmaceutical manufacturers of the same varieties in principle should be completed within 3 years of consistency evaluation. Can this goal be achieved on schedule? What variables exist in the meantime?
Tu Honggang: With the release of the official documents for injection consistency evaluation, the previously accumulated declaration approvals of CDE are expected to begin to pass the review in the coming months. Since the time frame requirement for the review is completed within 120 days of acceptance, the replacement should be completed at one time within 4 months, taking into account that some varieties may need to undergo at least one replacement, the individual believes that the actual time required to pass the review may take 8 months on average, so the first to report the consistency evaluation, review the serial number of the top part of the varieties, is expected to be evaluated before the end of this year. In addition, the state will also introduce supporting measures, collection and health insurance will be tilted to the evaluation of the variety, and three years later if there has not been an evaluation, while the market more than three over review, it is likely to refer to oral preparations, can not sell nor let buy, so I personally think that the above-mentioned goals can be achieved. Variables will appear in some high process difficulty and market value of small varieties, there may be delays, but not the overall situation!
Qi Zhengwei: With the oral solid preparation consistency evaluation work, the awareness of production enterprises to further improve, especially the popularization and rapid promotion of the volume procurement, become an important promotion factor for injection consistency evaluation, combined with the same period of injection reference preparation catalog, injection consistency evaluation technical requirements, injection consistency evaluation reporting data requirements, there is reason to believe that the completion of injection consistency evaluation mission is a large probability event.
Guo Xinfeng: From the current policy point of view, should be the first to start, while the side of the improvement. For the three-year constraint, the current industry most of the view is nothing, consistency evaluation needs to reduce administrative intervention, more to the market to choose. Supporting policies and measures, still need to be further improved with the injection consistency evaluation, rather than all complete and then start consistency evaluation, time can not afford.
Shrichen: Personally, it is very difficult to complete on schedule. Now the approval process is no problem, the enterprise also has no problem, mainly be test clinical institutions small number of problems, if reached 1000, three years to complete no problem. But the number of clinical research units is not solved, not to mention three years, five years will not be able to complete.
: In accordance with the policy requirements, varieties through consistency evaluation are given priority into the national list of essential drugs, and varieties that fail consistency evaluation will be gradually transferred out of the catalogue. According to industry forecasts, in the second half of this year or next year, the national base medicine catalog will be adjusted again. Will this help pharmaceutical companies to speed up the progress of consistency evaluation? qi Zhengwei,
: The national list of basic drugs has become one of the important thresholds for the procurement of medicines in public hospitals at all levels, and the proportion of medicines purchased by state-based drugs in different levels of hospitals is clearly defined. The next step of the adjustment of the national basic drug catalogue and the integration of consistency evaluation will undoubtedly promote enterprises to accelerate the pace of consistency evaluation. Because manufacturers clearly see that generics will be difficult to establish a foothold in public hospitals without consistency evaluation.
Tu Honggang: From the direction of medical reform, through the consistency evaluation of varieties, grade hospital drug ranking varieties, as well as the treatment of severe and extremely large diseases of innovative drugs, are expected to be included in the new version of the base drug. Because of the compulsory use of medical institutions, from the point of view of drug marketing, can eliminate the development of medical institutions and the amount of work, the attraction of pharmaceutical companies is greater. Every time the base drug catalog adjustment, for pharmaceutical companies is also a "big test", we are all trying to break the head to drill into the base drug catalog. Therefore, the country is using economic leverage and entry threshold two-wheel drive to accelerate the progress of consistency evaluation, the scale of pharmaceutical companies will certainly go all out, some small pharmaceutical companies may self-abandon, showing polarization, the overall will accelerate the progress! guo Xinfeng,
: The dividend of basic medicine will be gradually released with the consolidation of basic medical care in the country, especially after the outbreak. And among them, the expansion of the base drug catalog, hospital equipment ratio requirements and other good has been arrow in the string, or will promote the drug companies injection consistency evaluation speed up.
Shi Lichen: Now is not a question of how enterprises do not evaluate consistency, but how to build the product structure of the future. In the future, poor economic efficiency, non-competitive products will be cut, such as Hengrui, East China Medicine are cut. On the basis of confirming the product direction and product structure, determine how the consistency evaluation is done and which varieties to do first. The current market is divided into three pieces: the policy market, mainly public hospitals; The future of the policy market is a large-scale market, profit soure will not be too high, the real profit is in the out-of-policy market. Therefore, to do consistency evaluation, can not just focus on the policy within the market.
Medical Observer: How much would the cost of an injection consistency evaluation be? qi Zhengwei,
: Statistics show that from January 2018 to October 2019, 61% of 65 oral preparations (excluding adoption) cost between 5 million and 10 million yuan. Compared with oral dosage form, the test cycle is shorter, the pharmaceutical test is mainly, the cost is relatively low, so the average injection consistency evaluation cost is about 3 million - 4 million yuan. However, special dosage forms (lipids, venous milk, microspheres, mixed suspension injections) also need to be BE trials / clinical trials, to be completed in about 2 years, the modified dosage form also needs to be re-made clinical trials. The cost of this kind of injection consistency evaluation is likely to be more than 10 million yuan.
Tu Honggang: the domestic institutions can undertake and carry out consistency evaluation is too few, which directly led to the previous oral solid preparation consistency evaluation price has reached 8 million - 10 million yuan. The key key points of injection consistency evaluation are the prescription process, primary auxiliary package quality control, and preparation quality research and control technology, which focus on safety. At present, the market single-species injection consistency evaluation costs from about 3 million yuan, some complex varieties are estimated to be more than 10 million yuan!
Shi Lichen: the consistency evaluation of oral solid sissic preparations has passed 10 million, so if the BE trial clinical research institutions are too few, the injection consistency evaluation price will be more than 10 million yuan. Moreover, China's injections are actually concentrated in large enterprises, large enterprises have money, then we will spell the price!
Guo Xinfeng: Injections because of the api, batch size, impurities, the cost of the cost between 3 million to 30 million, including CRO pharmacy or clinical research costs, as well as raw materials, accessories and package research costs.
Pharmaceutical Observer: Will more injections be included in the next batch of tape purchases? Which varieties will be the first to enter?
Tu Honggang: According to the rules, high sales, large market range and has passed the consistency evaluation of the injection, it is very likely to be included in the collection range. Data from the Emmett sample public hospital show that 2019 has passed a consistency evaluation, and the injection sales in the not-in-the-country range of TOP10 are moxisacs, dositas, Idalafon, ampichimolo, iodide, calcium of naloxin, dosocho, pyrethroids, heparin sodium, ketone saccharinol, so these varieties are expected to be included in the collection. In addition, there are currently 153 injection varieties have been submitted by enterprises consistency evaluation supplement applications, including hydrochloric acid ammonia bromine injection, injection of cephalosporine sodium, injection of omeprazole sodium, injection of parisibdiazepine, injection of cephalosporine and other large varieties may be the first to be included in the collection.
Qi Zhengwei: divided into two cases, one is the national version of the volume of procurement, according to the evaluation of the number of injection manufacturers constitute a competition.