Consistency Evaluation Speed Up Thousand Thousand Injections Pharmaceutical Companies Face Big Shuffle

In October 15th, the State Food and Drug Administration issued the technical requirements for evaluating the quality and efficacy of chemical injection generic drugs (Draft). In the industry's view, this marks the start of the long-awaited consistency evaluation of injections.

According to China Health CMH data, in 2016, the scale of domestic injections was 757 billion 700 million yuan, chemical drug injection accounted for 72% of the total annual sales volume was about 545 billion 500 million yuan, and according to previous GMP certification data, more than 1000 domestic enterprises produced injections. Therefore, the consistency evaluation of generic injection is considered to be a heavy policy that will affect the pharmaceutical industry structure and subvert the pharmaceutical industry.

In October 17th, Wang Ying, CEO, told reporters in an interview with the economic report in twenty-first Century that generic drugs and injections accounted for more than 80% of the public hospital market, of which injection accounted for about 2/3, and the consistency evaluation of solid preparations came to an end. Under the superposition of the policy of quantity purchasing in the 4+7 City, there are two opposite attitudes towards the consistency assessment of the generic drug companies at present, or they should take an active part in the competition, take the tickets to fight for the market price, or give up the consistency evaluation, evaluate the enterprise situation and product situation, and seek transformation. He said.

According to Shi Lichen, founder of Ding Chen medical management consulting and management center, the state requires consistency evaluation of chemical injection generic drugs to improve the quality of drugs and solve historical problems. "Consistency of injection evaluation is just like drugs. Now the cost is more than 800-1000 yuan, and the resources of the original BE test are very tight. It is expected that the 20%-30% enterprises will produce injections after this consistent evaluation and the background of national drug gathering."

Shi Lichen believes that under the general trend of state gathering and drug price reduction, enterprises have completed the evaluation of consistency. They are getting tickets. But ultimately, the core of chemical injection is still raw material. Many large pharmaceutical companies have expressed relevant views to the twenty-first Century economic report reporter. But in the past week, many of the heads of API have declined relevant interview requests, and even do not wish to make any comments on anonymity.

Speed evaluation of injection consistency

Since February 27, 2017, when the original CFDA leader explicitly launched the re evaluation of injections at the news conference of new China office, the documents on consistency evaluation of injections have also been released, but there are no specific details.

Some media use "Silence" to describe the promotion of injection consistency evaluation policy.

Injections appear in the list of reference preparations to guide the consistency evaluation of generic drugs, which is regarded as a precursor for the official to start the consistency evaluation of injections. Since the twenty-first batch of reference preparations were released by the center for drug control in March 2019, the varieties of injection have been concentrated. Up to the twenty-fourth batch, the drug trial center has released 628 injection reference preparations.

In the industry view, the draft is the official start sign for consistency evaluation of injections. Compared with the 2017 edition, the content has been slightly changed. It has put forward higher requirements for the raw materials, auxiliary materials, packaging materials, filling processes and specifications of the domestic enterprises.

In fact, the goal of consistency evaluation of injections is to improve the quality and safety of drugs. In October 15th, the annual report of national adverse drug reaction surveillance (2018) released by the State Drug Administration's Drug Evaluation Center showed that injection accounted for more than 60% of adverse drug reaction / event reports.

Shi Lichen pointed out to the twenty-first Century economic report reporter that this is actually to make up for the problems left over by history. From simple "imitation standard" to "high imitation" stage of technology and research and development level, many products with poor clinical safety and no effective advantages will be eliminated, and they can also make room for medical insurance funds.

Polarization of pharmaceutical enterprises

For consistency assessment, Wang Ying pointed out to the twenty-first Century economic report reporter that at present, domestic enterprises are showing two totally different attitudes.

Some of them are actively involved in consistency evaluation. Although at the end of 2017, CDE announced the solicitation comments on the injection conformance evaluation of the listed companies, although the official manuscript had not been released at that time, 56 companies have submitted supplementary applications for consistency evaluation of injections.

As at the end of September, the number of supplementary applications received by CDE for injection consistency evaluation was 445, involving 123 species. The number of injections accepted by CDE under the new registration classification (3 categories, 4 categories and 5.2 categories of imports) was 481, involving 192 varieties.

According to statistics, the company has submitted 76, involving 46 varieties, and Qilu pharmaceutical industry has 55 acceptance numbers of 32 varieties.

"Another direction is that many enterprises have abandoned consistency evaluation and are doing transformation. It includes seeking outside hospital pharmacy market, which is a relatively fast market outlet for traditional generic drug companies, or taking OTC and big health market direction. Another kind of transformation is high-end medical market and private hospital market, which is little affected by policy. " Wang Ying pointed out.

According to Wang Ying analysis, the information obtained by pharmaceutical companies is more consistent than that of the original research drugs. But the state directly reduces the price of the original research drugs to the floor price through 4+7. Under such circumstances, if the enterprises that control the production costs are not able to achieve consistency, they will not necessarily be able to win the bid.

API is still the core of competition.

"Consistency evaluation of injections is the same as solid preparations. The cost of a variety is more than 800-1000 yuan, and the resources of BE test are relatively tight when the chemicals were used for consistency evaluation, and the injection of this part will be more stressful." Shi Lichen pointed out that many enterprises will consider the cost and other issues will give up the consistency evaluation of injections, which will naturally eliminate a number of enterprises.

Moreover, in combination with the concept of rational use of drugs that can be injected intramuscularly and without intramuscular injection, the use of injections has been gradually limited, including the "restriction order", the stop of transfusion in the third class a hospital, and the key monitoring list, which has a great impact on the market of injections, such as traditional Chinese medicine injections.

Under the superposition of multiple factors, Shi Lichen pointed out that a large number of injection related enterprises will be eliminated. "Before GMP asepsis certification, there were more than 1000 enterprises producing injections. After this round of consistency evaluation, it is expected that the industry can only have 20%-30% related production enterprises."

As mentioned above, many enterprises are facing transformation. However, many industry analysts believe that the share of public hospital procurement will still be relatively large in the future, and whether it is solid pharmaceutical or injection production enterprises, in the background of national collection and medical insurance control, "get the market for raw materials."

Prior to this, in the procurement bidding of 4+7 city belt, many pharmaceutical companies directly hit the floor price, and the biggest emboldened was the control of API. The chief executive of the Cologne pharmaceutical company told the economic news reporters twenty-first Century that the biggest advantage is the integration of raw materials. Xu Haiying, general manager of Harbin Pharmaceutical Group, also admitted to the twenty-first Century economic report reporter that although Harbin Pharmaceutical Group has not been able to evaluate the consistency of drugs at present, but because of the integration of raw materials preparation, it will still have important advantages in the future competition.

However, restricted by the national production and approval system of raw materials, many enterprises are unable to grasp the raw material drugs, and are obviously at a disadvantage in competition, and are often involved in the monopoly of raw materials, and the cost is constantly improving. One industry insider told the twenty-first Century economic news reporter that at present, a leading enterprise in China is constantly raising prices due to the price of API, leading to soaring costs, and is in litigations with related enterprises.

The importance of APIs is self-evident. Many large pharmaceutical companies have expressed their views to the twenty-first Century economic news reporter.

"Enterprises are very sensitive now, but raw material is the key to the competition of enterprises. The key to solve this problem is that it is still necessary to adjust the production license system to the filing system, which is also an international practice. This can prevent the monopoly of raw materials and reduce the cost of pharmaceutical enterprises, so as to achieve the ultimate goal of drug price reduction. Shi Lichen pointed out to the twenty-first Century economic news reporter.

The high price of API causes the rising cost of drugs, which stems from the fact that the supply of raw materials is less than that of demand. Since the manufacturers of APIs must be approved by the relevant departments of the state, they will be able to produce them, and the number of manufacturers authorized to produce them is small. Once the producers secretly form alliance or dealer forming alliances, control the supply of raw materials in the market, the price of the raw materials will be artificially raised.

Liu Qun, chairman of Chongqing Tiansheng pharmaceutical company, said in an interview with the economic news reporters in twenty-first Century that solving the problem of bulk drug monopoly needs to release the approval of the crude drug. The raw material is not included in the drug administration, and the raw material is the chemical medicine, which is the chemical product and is not included in the drug administration.

Du Zhenxin, chairman of Shandong Chen Xin Pharmaceutical Company, suggested that the DMF filing system should be implemented. In most countries of the world, the DMF registration system is applied to the API, that is, the examination and approval system is prior management, and DMF is a matter of management after and after the event. The DMF mechanism has strengthened the sense of responsibility for the raw materials used by the preparation enterprises, and they are the real responsible subjects for the raw materials they need.