The business club reported on March 1st that in a multi-player game in which "you have me and I have you", you can enter the international generic market, especially the European and American markets, and build a "Made in China" brand. This will not only expand the international market. Market share, digesting domestic excess capacity, and more importantly, is crucial in securing domestic market share and acquiring the initiative in both domestic and foreign markets.
Before the Spring Festival, the author was invited to visit the United States. Before going to the United States, he was busy with the improvement and revision of the "12th Five-Year Plan" of the national pharmaceutical industry. Many of the difficult problems needed to be solved could not find a suitable answer. This visit helped the author find some inspiration.
During this period of time, the author has been focusing on the international generic drug market. This is not only the need for the development trend of the global pharmaceutical market, but also the most important step in the transformation and upgrading of China's pharmaceutical industry within the next five years or even longer. One of the battlefields.
Whether it can win a place in the increasingly fiercely competitive international generics market is crucial for Chinese pharmaceutical companies.
In a multi-player game where you have me and you have me, you can enter the international generic market, especially the European and American markets, and build your “Made in China†brand. This will not only expand your international market share, but also absorb domestic excess capacity. More importantly, it is crucial in ensuring the domestic market share and acquiring the initiative in both domestic and foreign markets. However, the actual situation is that most enterprises in China do not make corresponding preparations.
The author believes that entering the international generic drug market, especially regulating the market, is not a point of entry, but the entire entry of the entire value chain, that is, the face to face.
In general, when entering the international generic pharmaceutical market, Chinese pharmaceutical companies need to pay attention to the following aspects.
Up to standard companies have been tested on their orders
At present, more than 20 domestic companies have reached the European and American pharmaceutical GMP regulations, and many companies are still in full swing to declare. However, compliance is only a necessary condition rather than a sufficient condition.
Among the companies that meet the standards, some enterprises have small production scales, while foreign orders are often time-critical and require large output. In terms of tablets, more than a billion or even a few billion tablets are more common. If the scale of production does not reach, how can we take orders? As a result, for companies with limited capacity, they either have to make a profit or lose money. It is difficult to recover the input for the GMP reform in the earlier period, or they can only bolster their existing capacity further.
Rational expectations of market returns
The generic market has limited profit margins in Europe and the United States. For example, the British government has strict control over the profitability of drugs in order to save medical expenses. In recent years, many companies have discovered that although there is a single connection, they do not make money. This has a direct bearing on the strict regulations of Western countries, especially countries that implement public-funded medical care, and the more they regulate the market, the harder it is to make money. This phenomenon actually embodies the essential properties of generic drugs, which are very different from the blockbuster patented drugs.
In recent years, some companies did not do a good job of market research, blindly launched the European and American GMP renovation projects, but the current situation of the general profitability of generic drugs in these markets is underestimated. How to adapt to the competitive situation of small profits and quick turnover as soon as possible, and to change the quality through quantitative changes has become a new topic.
Get ready for legal preparations
In order to make up for the loss of time in the early development process, European and American countries adopted an administrative protection for the original research medicine whose patent has expired, that is, exclusive protection of the market.
For example, according to the new regulations promulgated by the European Union in 2004 (No. 726/2004) and the two amended Directives 2004/27/EC (Personal Drug Use Directive) and 2004/28/EC (Veterinary Medicinal Instruction), all are approved in accordance with the centralized approval process. After the expiry of the patent, the original research drug has an exclusive period of “8+2+1 yearâ€, ie, an eight-year data exclusivity period plus two years of market protection period for a total of ten years.
In addition, if the original research company’s product is approved for a new treatment indication within 8 years of data exclusivity, the data exclusivity period can be extended by another year to 11 years. For some veterinary drugs, it can be extended to 13 years. Prior to this, the original research medicines approved by Belgium, Germany, France, Italy, the Netherlands, Sweden, the United Kingdom and Luxembourg had a 10-year data exclusivity period and were approved by Austria, Denmark, Finland, Greece, Ireland, Iceland, Norway, Portugal and Spain. The original research medicine has only 6 years of data exclusive period. During the period of market exclusivity, any listing application for generic drugs cannot be approved.
Currently, Hisun Pharmaceutical has obtained approval for the marketing of fluvastatin and tacrolimus in the United Kingdom and Spain respectively. Among them, tacrolimus is the first generic generic drug approved in the European Union. In the United States, according to the Waxman-Hatch method passed in 1984, if a generic drug is to be marketed through the ANDA method, the original product must be patented. After successful patent challenges, they may enjoy 180 days of market exclusivity. Up until now, except for Shuanghe Pharmaceutical's acquisition of Ranbaxy's meloxicam ANDA 78039 in 2008, there is no second company in China that has obtained ANDA approval in the United States. Regarding the numerous operational issues involved in the above-mentioned application at the legal level, it is still a minority that truly understands and uses domestic companies with ease.
Strive to enter the National Health Insurance Directory
To regulate the national market in Europe and the United States, in order to obtain continuous large orders and increase product sales to an appreciable level, it must enter the local national free medical reimbursement or commercial insurance catalog. However, this is very difficult for domestic companies. The difficulty is that our basic work is not yet in place.
First of all, the reimbursement system for different countries has not been fully investigated, and entry strategies cannot be formulated in different ways. Second, China's pharmacoeconomic evaluation, especially for the international market, is still at the textbook level. How to bundle with the products of the companies that go out and provide a large number of detailed, reliable, accurate, and scientific economic foundations according to the requirements of different target markets, there are still few attempts.
Second, with the entry of products, public relations lobbying by government agencies, industry associations, and intermediary review agencies in target markets creates positive influences and thus opens up a breakthrough at the high-end level.
Marketing network must be widened again
In Europe and the United States, the concentration of pharmaceutical and commercial circulation markets is relatively high. For example, the top three commercial companies in the United States account for more than 90% of the pharmaceutical sales in the United States, but the degree of concentration does not mean that they can pack the world.
Some commercial companies are mainly hospital wards, and some are supermarkets and retail pharmacies. Due to the strong regional sales of European and American generic pharmaceutical companies and their own sales network as early as in the region, domestic companies must accurately choose their own marketing partners and conduct promotional activities in a targeted manner. Otherwise, they will lose half the effort.
According to the successful practice of Indian companies operating in Europe and the United States in recent years, localization of product sales through mergers and acquisitions or participation in local commercial companies is a short cut. This point, domestic companies have yet to break through.
A few years ago, we were pleasantly surprised that Shenzhen Mindray Company branded its products with the Mindray brand and dignifiedly entered the British NHS system. This is the first Chinese pharmaceutical company to enter the government's medical procurement system with its own brand abroad. However, up till now, China's pharmaceutical companies have only gone through commissioned processing or OEM production. The lack of brands has become a common phenomenon.
In the current “conflict of Chinese medicine†that has encountered the international crisis of confidence, it is expected that companies that dare to take the lead in the world will take the lead in this step.
Before the Spring Festival, the author was invited to visit the United States. Before going to the United States, he was busy with the improvement and revision of the "12th Five-Year Plan" of the national pharmaceutical industry. Many of the difficult problems needed to be solved could not find a suitable answer. This visit helped the author find some inspiration.
During this period of time, the author has been focusing on the international generic drug market. This is not only the need for the development trend of the global pharmaceutical market, but also the most important step in the transformation and upgrading of China's pharmaceutical industry within the next five years or even longer. One of the battlefields.
Whether it can win a place in the increasingly fiercely competitive international generics market is crucial for Chinese pharmaceutical companies.
In a multi-player game where you have me and you have me, you can enter the international generic market, especially the European and American markets, and build your “Made in China†brand. This will not only expand your international market share, but also absorb domestic excess capacity. More importantly, it is crucial in ensuring the domestic market share and acquiring the initiative in both domestic and foreign markets. However, the actual situation is that most enterprises in China do not make corresponding preparations.
The author believes that entering the international generic drug market, especially regulating the market, is not a point of entry, but the entire entry of the entire value chain, that is, the face to face.
In general, when entering the international generic pharmaceutical market, Chinese pharmaceutical companies need to pay attention to the following aspects.
Up to standard companies have been tested on their orders
At present, more than 20 domestic companies have reached the European and American pharmaceutical GMP regulations, and many companies are still in full swing to declare. However, compliance is only a necessary condition rather than a sufficient condition.
Among the companies that meet the standards, some enterprises have small production scales, while foreign orders are often time-critical and require large output. In terms of tablets, more than a billion or even a few billion tablets are more common. If the scale of production does not reach, how can we take orders? As a result, for companies with limited capacity, they either have to make a profit or lose money. It is difficult to recover the input for the GMP reform in the earlier period, or they can only bolster their existing capacity further.
Rational expectations of market returns
The generic market has limited profit margins in Europe and the United States. For example, the British government has strict control over the profitability of drugs in order to save medical expenses. In recent years, many companies have discovered that although there is a single connection, they do not make money. This has a direct bearing on the strict regulations of Western countries, especially countries that implement public-funded medical care, and the more they regulate the market, the harder it is to make money. This phenomenon actually embodies the essential properties of generic drugs, which are very different from the blockbuster patented drugs.
In recent years, some companies did not do a good job of market research, blindly launched the European and American GMP renovation projects, but the current situation of the general profitability of generic drugs in these markets is underestimated. How to adapt to the competitive situation of small profits and quick turnover as soon as possible, and to change the quality through quantitative changes has become a new topic.
Get ready for legal preparations
In order to make up for the loss of time in the early development process, European and American countries adopted an administrative protection for the original research medicine whose patent has expired, that is, exclusive protection of the market.
For example, according to the new regulations promulgated by the European Union in 2004 (No. 726/2004) and the two amended Directives 2004/27/EC (Personal Drug Use Directive) and 2004/28/EC (Veterinary Medicinal Instruction), all are approved in accordance with the centralized approval process. After the expiry of the patent, the original research drug has an exclusive period of “8+2+1 yearâ€, ie, an eight-year data exclusivity period plus two years of market protection period for a total of ten years.
In addition, if the original research company’s product is approved for a new treatment indication within 8 years of data exclusivity, the data exclusivity period can be extended by another year to 11 years. For some veterinary drugs, it can be extended to 13 years. Prior to this, the original research medicines approved by Belgium, Germany, France, Italy, the Netherlands, Sweden, the United Kingdom and Luxembourg had a 10-year data exclusivity period and were approved by Austria, Denmark, Finland, Greece, Ireland, Iceland, Norway, Portugal and Spain. The original research medicine has only 6 years of data exclusive period. During the period of market exclusivity, any listing application for generic drugs cannot be approved.
Currently, Hisun Pharmaceutical has obtained approval for the marketing of fluvastatin and tacrolimus in the United Kingdom and Spain respectively. Among them, tacrolimus is the first generic generic drug approved in the European Union. In the United States, according to the Waxman-Hatch method passed in 1984, if a generic drug is to be marketed through the ANDA method, the original product must be patented. After successful patent challenges, they may enjoy 180 days of market exclusivity. Up until now, except for Shuanghe Pharmaceutical's acquisition of Ranbaxy's meloxicam ANDA 78039 in 2008, there is no second company in China that has obtained ANDA approval in the United States. Regarding the numerous operational issues involved in the above-mentioned application at the legal level, it is still a minority that truly understands and uses domestic companies with ease.
Strive to enter the National Health Insurance Directory
To regulate the national market in Europe and the United States, in order to obtain continuous large orders and increase product sales to an appreciable level, it must enter the local national free medical reimbursement or commercial insurance catalog. However, this is very difficult for domestic companies. The difficulty is that our basic work is not yet in place.
First of all, the reimbursement system for different countries has not been fully investigated, and entry strategies cannot be formulated in different ways. Second, China's pharmacoeconomic evaluation, especially for the international market, is still at the textbook level. How to bundle with the products of the companies that go out and provide a large number of detailed, reliable, accurate, and scientific economic foundations according to the requirements of different target markets, there are still few attempts.
Second, with the entry of products, public relations lobbying by government agencies, industry associations, and intermediary review agencies in target markets creates positive influences and thus opens up a breakthrough at the high-end level.
Marketing network must be widened again
In Europe and the United States, the concentration of pharmaceutical and commercial circulation markets is relatively high. For example, the top three commercial companies in the United States account for more than 90% of the pharmaceutical sales in the United States, but the degree of concentration does not mean that they can pack the world.
Some commercial companies are mainly hospital wards, and some are supermarkets and retail pharmacies. Due to the strong regional sales of European and American generic pharmaceutical companies and their own sales network as early as in the region, domestic companies must accurately choose their own marketing partners and conduct promotional activities in a targeted manner. Otherwise, they will lose half the effort.
According to the successful practice of Indian companies operating in Europe and the United States in recent years, localization of product sales through mergers and acquisitions or participation in local commercial companies is a short cut. This point, domestic companies have yet to break through.
A few years ago, we were pleasantly surprised that Shenzhen Mindray Company branded its products with the Mindray brand and dignifiedly entered the British NHS system. This is the first Chinese pharmaceutical company to enter the government's medical procurement system with its own brand abroad. However, up till now, China's pharmaceutical companies have only gone through commissioned processing or OEM production. The lack of brands has become a common phenomenon.
In the current “conflict of Chinese medicine†that has encountered the international crisis of confidence, it is expected that companies that dare to take the lead in the world will take the lead in this step.
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