China's first generic drug lost in the market: where and where?

Source: medicine Rubik's cube Author: Huang Yi 2016-05-23 in addition to innovative drugs, the first generic drugs that are about to expire in patent competition are probably the most popular research and development of Chinese medicine Looking at the annual review reports of CDE in recent years, an obvious trend is the soaring number of first generic drugs declared in category 3.1 With the development of the patent cliff of multinational pharmaceutical companies and the improvement of domestic R & D capacity, a large number of local enterprises began to follow up quickly, competing for the first domestic imitation of heavy bombs In the queue sequence displayed by CDE, including popular ones such as sorafenib, tofatibu, cagregrini, gefitinib, and rivaroxaban, almost every heavy drug's first imitation queue sequence is crowded with three or four enterprises, more than eight or nine enterprises, including Qilu, Hengrui, hausen, Zhengda Tianqing, Shiyao, Kelun, aosaikang and many other big players As we all know, the difficulty and cost of the development of the first generic drugs are lower than that of the innovative drugs, the efficacy of the products has been verified, and the market foundation has been fully paved by foreign companies Once the enterprise wins the first imitated listing, it is expected to rapidly replace the expensive original research products with low price In terms of pricing policy, it also has more advantages than the follow-up, which seems to be a "less investment, low risk, quick effect" business In the European and American markets, the success of Teva, Sandoz and other generic pharmaceutical companies is also an example of this view Those leading enterprises in the queuing sequence of first-time imitation of heavy drugs are often expected to compete at a high speed Once the first-time imitation is achieved, the enterprises will naturally get rich returns But is it true? Frequent failures of China's first imitation: the gap between ideal and reality we selected nearly 20 well-known and heavyweight varieties that have been listed in China, including many important treatment fields, which are respectively in the forefront of annual sales in their respective fields, most of which have been listed for more than 10 years According to the data of Zhongkang CMH, we compared the market share of the same kind of products in 2013 between the original research foreign enterprises and the domestic first imitation enterprises, hoping to observe the competition pattern of the first imitation drugs and the return for the corresponding enterprises The statistical results may come as a surprise to many people: in most cases, except for some areas of treatment, the successful first imitated listing did not bring the enterprises the success they imagined Market share comparison of the top selling varieties in some treatment fields in 2013: original research & first copy source: Zhongkang data CMH tumor drug is the advantage battlefield of domestic generic drug enterprises No matter how many first imitated Hengrui, hausen or quick follow-up Qilu pharmaceutical, their market share is no less than that of foreign pharmaceutical companies with original research products In addition to the listed varieties, other domestic first imitated antitumor drugs such as gemcitabine and irinotecan also have market advantages In addition, the domestic first imitation is also in an advantageous position in some gastric ulcer drugs, and the market performance of aosaikang and Luoxin is also very good, although not necessarily the first imitation In addition, in many other major fields, including hypertension, hyperlipidemia, antithrombotic, diabetes, antidepressant, asthma, etc., in the same competition of the first imitation and the original research varieties, the performance of the domestic first imitation enterprises are mostly unsatisfactory Many of the original varieties whose patents have expired for many years often occupy 50% - 60% of the market share and 70% - 80% of the market share The market share is based on the total sales, and most of the original research has higher prices than the first imitation, but what about the impact of this factor aside? A number of studies have shown that in the Chinese market, the price of original research is about twice that of the first imitation Even the first generic drugs on the market are mostly for this reason For example, if Zhengda Tianqing imitates the pricing announced by dashatini for the first time, according to the BMS model of three free nine, the price is also one-half of the original research product If it is a classic old medicine with patent expired for many years, the price difference between the original research and the first imitation is less However, in the comparison of many varieties, the gap between the market share of the original research and the first imitation even exceeds the price gap For example, the prices of atorvastatin, acarbose, clopidogrel and other varieties in the original research are less than twice or even smaller than those in the first research, but the total sales volume has reached twice or nearly four times of that in the first research, which means that many first research varieties with price advantages and local advantages have not been better than those in the original research Today, with the collective rise of Chinese enterprises, such a situation is rare in other industries In other foreign markets it's a different story Good quality and cheap generic drugs have a huge market in the United States In 2011, Forbes reported the list data of 15 most popular drugs in the United States Except Lipitor, all of them are cheap generic drugs after the expiration of heavy-duty product patents Many Chinese pharmaceutical executives who have worked in the United States should have similar perceptions Similarly, in Europe, when the government controls the medical expenditure vigorously, the generic medicine is often the overwhelming advantage to the original research medicine From this point of view, at least so far, for most Chinese pharmaceutical enterprises, the first imitation has not brought enough rich returns to the enterprises as the international counterparts After planting the Dragon species, although the harvest is not a flea, it is far from the ideal What are the reasons for this difference? What is China's first short board imitation: quality or business? We explore the reasons for the poor performance of the first imitated products market of Chinese pharmaceutical companies from two aspects: product quality and marketing Product quality: the R & D and production process of the Chinese generic group pharmaceutical enterprises with uneven differences determine the product quality So far, China's generic drug consistency evaluation has not been carried out in a large area, but from the intuitive sense, the generic drugs of Chinese enterprises as a whole are not as good as the original research drugs, which is also generally agreed by the insiders Clinicians have more say in the market audience Recently, there was a media investigation on the quality of domestic generic drugs It was concluded that nearly 90% of clinicians believed that the quality of the original drugs was good, which was confirmed from the side However, it should be noted that compared with less than 200 pharmaceutical enterprises in the United States, there are more than 4000 pharmaceutical enterprises in China, most of which may be regional enterprises with very backward scale and technology Nevertheless, they still have the legal qualification of producing and selling generic drugs On the whole, these "small and scattered" enterprises still occupy a considerable scale in the Chinese market, especially in the middle and basic level market The impression of poor quality of domestic generic drugs may be partly attributed to this group On the other hand, we should also see that a number of excellent enterprises represented by Qilu, Hengrui, Yangzi River, Shiyao, Haizheng, Huahai, etc are increasingly passing the GMP certification of developed countries in Europe and the United States, and clinical experts also have a high degree of recognition for their products At least we have more confidence in the imitated varieties of these excellent pharmaceutical enterprises Generally speaking, in terms of product quality, China's generic drugs show a differentiated distribution: a few excellent enterprises' products should be comparable to the original research drugs, but most of them are far from each other The same is true of my intuitive feelings I have heard that a clinical expert of Hematology in China has given a fairly high evaluation on the quality of Qilu's EPO, and I have purchased a brand of acetaminophen from a retail drugstore in China Its preparation powder can adhere to the aluminum plate, so the curative effect is natural and needless to mention Marketing: the short board of management awareness, resource allocation and consumption environment analyzes the marketing situation of China's first generic drugs carefully, and the gap between enterprises in this respect may be even greater Many first-time imitators attribute the failure of product competition to policy factors such as recruitment standard Indeed, foreign enterprises have invested heavily in government affairs and public relations, including bidding, medical insurance, basic medicine and many other aspects What's more, the relevant associations lobbied the high-level government to suppress the competition of domestic imitation varieties in the name of "one product, two regulations" and other policies Many newly launched first imitation products, to some extent, will be subject to such access threshold For example, domestic imatinib, which was first imitated and listed in 2013, can only be sold in limited provinces so far But such problems are not insurmountable At present, most of the provinces have also set up the record entry system for bidding, which is the way for Zhengda Tianqing's first imitation of dashatini to enter Shandong, Hubei and other markets As for access to medical insurance, generic drugs should have more price advantages Moreover, in recent years, more and more provinces have begun to carry out independent negotiations on major types of medical insurance Therefore, government affairs are not absolutely obstructed, but enterprises need to have enough consciousness and invest human and energy to operate The allocation of marketing resources is really the short board of Chinese enterprises Most people in the industry know that foreign enterprises invest a large amount of resources in product marketing, while the number of product specifications is small On the contrary, the total investment of domestic enterprises is insufficient, and the quantity of product regulations is often more than that of foreign enterprises On average, the marketing and promotion resources of a single product, including human resources, visit frequency, meeting expenses and many other aspects, naturally have a larger gap Take human resources as an example Even for the original research products with expired patents, foreign enterprises often operate a product with multiple people in key regions On the contrary, in domestic enterprises, it is normal for one person to operate multiple products Some enterprises with poor marketing strength, even if they get the first copy, are difficult to operate in areas with weak market, and often directly throw it to agents Foreign companies often operate their original research products for many years Whether it is expert network or academic support, they are often familiar with them These accumulated advantages will not disappear with the expiration of patents Moreover, the marketing department, the medical department and many other supporting departments cooperate to fight In terms of the influence of the market of similar varieties, the first domestic imitated varieties are really difficult to match Objectively speaking, most of the domestic enterprises are quite original in the management of the marketing team The enthusiasm of the sales representatives and even the individual strength may not be inferior to that of the foreign enterprises However, the excellent individual strength is still hard to resist in the face of the positive hand in hand of the same type and the joint operation of the sea, land and air of the other side After the first imitated listing of domestic enterprises, the selling point is often a novelty: my product quality is not inferior to the original research, but the price is much lower Whether or not the quality can really reach the original research level, only such selling points are indeed unattractive in the domestic pharmaceutical consumption environment scene In the U.S market, the payers take rational decisions such as PBM and insurance companies as the main body, and the cost-effectiveness ratio is often the focus of their attention In the Chinese market, doctors are the main body of drug consumption decision-making, efficacy is its core demand, and price sensitivity is much weaker If the first generic medicine can only play the price advantage card, its appeal to the real consumer decision-makers is very limited In a word, the annual accumulation of the original research products in the relevant treatment fields and the strong strength of marketing resource allocation make them have natural advantages in the face of the first imitated varieties; while the domestic first imitated varieties are lack of academic evidence, and the unique price advantage of the imitated drugs is not obvious in China's consumption environment If the quality can't keep up, the overall failure is Milli