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Pharmaceutical Net, June 18th.
Under the background of the normalization of mass procurement, chemical generics companies are actively seeking to break the situation.
Some companies extend upstream and integrate development to control costs; some companies deploy first generic drugs and transform and upgrade; there is another part.
Companies actively expand overseas sales channels and develop overseas
.
Under the background of the normalization of mass procurement, chemical generics companies are actively seeking to break the situation.
Some companies extend upstream and integrate development to control costs; some companies deploy first generic drugs and transform and upgrade; there is another part.
Companies actively expand overseas sales channels and develop overseas
.
According to the newly revised " Administrative Measures for Drug Registration", categories 3 and 4 are generic drugs
.
The research and development path of domestic innovative preparations is mainly imitation, and confirmatory clinical trials are required before the registration classification is changed
.
According to the new registration scheme, generic drugs of categories 3 and 4 have the same attributes and specifications as the original drugs, so they only need to pass the bioequivalence (BE) test.
The development cycle is estimated to be 28 to 32 months
.
Compared with innovative drugs, generic drugs have a shorter R&D cycle and lower cost
.
.
The research and development path of domestic innovative preparations is mainly imitation, and confirmatory clinical trials are required before the registration classification is changed
.
According to the new registration scheme, generic drugs of categories 3 and 4 have the same attributes and specifications as the original drugs, so they only need to pass the bioequivalence (BE) test.
The development cycle is estimated to be 28 to 32 months
.
Compared with innovative drugs, generic drugs have a shorter R&D cycle and lower cost
.
At present, the proportion of American generic drugs in prescription drugs has reached about 90%, and the proportion of the amount is only about 10%; while the proportion of the amount of generic drugs in China is still more than 70%, accounting for a relatively high proportion
.
With reference to the US path, the proportion of total domestic sales of generic drugs will show a downward trend in the future
.
.
With reference to the US path, the proportion of total domestic sales of generic drugs will show a downward trend in the future
.
Extension of integrated development upstream
The Water Pollution Prevention and Control Action Plan issued by the State Council in 2015 had a profound impact on the API industry.
Many small and medium-sized API companies closed down and permanently withdrew from the market
.
According to data from the National Food and Drug Administration, China's API and preparation manufacturers reached 5,065 in 2015, but this dropped to 4,176 in 2016
.
The removal of high-polluting small and medium-sized enterprises has greatly optimized the industry competition pattern and increased industry concentration
.
Many small and medium-sized API companies closed down and permanently withdrew from the market
.
According to data from the National Food and Drug Administration, China's API and preparation manufacturers reached 5,065 in 2015, but this dropped to 4,176 in 2016
.
The removal of high-polluting small and medium-sized enterprises has greatly optimized the industry competition pattern and increased industry concentration
.
At the same time, the price of preparations purchased in quantities has dropped significantly, and the trend of vertical integration of generic pharmaceutical companies is obvious
.
According to statistics, the average price cuts of the five batches of nationally adopted generic drugs are all above 50%
.
At this time, the sales expenses, which accounted for about 40% of the old drug sales model, were almost completely squeezed, and the profitability of generic drug companies almost came from cost control and production efficiency
.
In the context of centralized procurement, the key to winning bids for companies is low cost.
Generic drug companies are expanding to the upstream field, and the development trend of industrial chain integration is obvious
.
.
According to statistics, the average price cuts of the five batches of nationally adopted generic drugs are all above 50%
.
At this time, the sales expenses, which accounted for about 40% of the old drug sales model, were almost completely squeezed, and the profitability of generic drug companies almost came from cost control and production efficiency
.
In the context of centralized procurement, the key to winning bids for companies is low cost.
Generic drug companies are expanding to the upstream field, and the development trend of industrial chain integration is obvious
.
Layout of the first generic drug transformation and upgrading
Since 2012, the annual sales of original research drugs whose patents expire each year have been between US$30 billion and US$60 billion, accounting for 4% to 7% of the global patented drug market
.
Due to the expiration of patents, the loss of the original research drug market caused by the entry of generic drugs into the market is between 15 billion and 36 billion US dollars per year
.
According to the prediction of Eval uate Phar ma, after the low patent expiration period in 2020 and 2021, there will be a new round of patent cliffs from 2022 to 2025.
The estimated market size of expired patent drugs is about 224 billion U.
S.
dollars.
.
.
Due to the expiration of patents, the loss of the original research drug market caused by the entry of generic drugs into the market is between 15 billion and 36 billion US dollars per year
.
According to the prediction of Eval uate Phar ma, after the low patent expiration period in 2020 and 2021, there will be a new round of patent cliffs from 2022 to 2025.
The estimated market size of expired patent drugs is about 224 billion U.
S.
dollars.
.
After the patent expired, both the original research drug and the generic drug experienced a cliff-edge price cut, especially after the patent expired one year after the overall decline was 51% (the decline of oral drugs was 66%)
.
At the same time, according to public data from the US FDA, competition will intensify and the price of generic drugs will decrease.
The first generic drug is about 94% of the price of the original drug.
After the second generic drug is launched, its price drops to 52% of the original drug.
The number of generic drugs continues to increase, and the decline continues to intensify.
When there are close to 20 generic drugs of the same variety, their prices have dropped to about 6% of the price of the original research drug
.
.
At the same time, according to public data from the US FDA, competition will intensify and the price of generic drugs will decrease.
The first generic drug is about 94% of the price of the original drug.
After the second generic drug is launched, its price drops to 52% of the original drug.
The number of generic drugs continues to increase, and the decline continues to intensify.
When there are close to 20 generic drugs of the same variety, their prices have dropped to about 6% of the price of the original research drug
.
Domestic high-quality generic drug companies have significant competitive advantages in the first generic drug market
.
Companies such as Hengrui, Hausen, Xinlitai, Chia Tai Tianqing, and East China Pharmaceuticals focus on high-quality generic drugs, which have been recognized and supported by a large number of institutions and clinical experts, and have established brand advantages .
Data shows that although the first generic drugs of these companies have been on the market for many years and other generic drugs have entered one after another, the market performance of these high-quality generic drug companies is still better than other generic drug companies and can maintain their share in the generic drug market .
.
Companies such as Hengrui, Hausen, Xinlitai, Chia Tai Tianqing, and East China Pharmaceuticals focus on high-quality generic drugs, which have been recognized and supported by a large number of institutions and clinical experts, and have established brand advantages .
Data shows that although the first generic drugs of these companies have been on the market for many years and other generic drugs have entered one after another, the market performance of these high-quality generic drug companies is still better than other generic drug companies and can maintain their share in the generic drug market .
Expand overseas channels and actively develop
In recent years, assisted by the domestic generic drug consistency evaluation policy, a large number of generic drug companies have survived the fittest, and are also actively exploring export markets on the premise of improving their own quality.
The number of abbreviated new drug applications (ANDA) approvals filed by Chinese pharmaceutical companies for export to the United States has continued to rise.
2018 ushered in the highest volume in history, with a total of 99 ANDA approvals obtained, of which 80 ANDA approvals have been approved, 19 are tentative approvals; in 2019, the number of ANDA approvals was 65
.
The number of abbreviated new drug applications (ANDA) approvals filed by Chinese pharmaceutical companies for export to the United States has continued to rise.
2018 ushered in the highest volume in history, with a total of 99 ANDA approvals obtained, of which 80 ANDA approvals have been approved, 19 are tentative approvals; in 2019, the number of ANDA approvals was 65
.
Huahai Pharmaceutical is a representative of the export of preparations
.
From 2015 to 2019, Huahai Pharmaceutical obtained approximately 80 ANDAs
.
While establishing an overseas marketing network and expanding overseas markets, the company has also begun to return to the local market.
Under the national centralized procurement policy, it has demonstrated its global synchronized quality system and cost control advantages in market competition
.
At the same time, the second and third echelon teams continue to grow, and the number of approvals has increased significantly.
In 2019, the new faces of Chinese companies that have been approved by the US ANDA include Hainan Shuangcheng, Zhengda Group and Jiangxi Boya
.
.
From 2015 to 2019, Huahai Pharmaceutical obtained approximately 80 ANDAs
.
While establishing an overseas marketing network and expanding overseas markets, the company has also begun to return to the local market.
Under the national centralized procurement policy, it has demonstrated its global synchronized quality system and cost control advantages in market competition
.
At the same time, the second and third echelon teams continue to grow, and the number of approvals has increased significantly.
In 2019, the new faces of Chinese companies that have been approved by the US ANDA include Hainan Shuangcheng, Zhengda Group and Jiangxi Boya
.
(Author's unit: Firestone Creation)
Further reading
Overview of the development of the U.
S.
and Japan generic drug industry
S.
and Japan generic drug industry
United States In 1984, the United States promulgated the "Drug Price Competition and Patent Term Compensation Act" (Hatch-waxman Act), which established a generic drug ANDA approach, and the amount of generic drugs gradually increased
.
Generic drug manufacturers only need to prove that the dosage form, specifications, active ingredients, and route of administration of the generic drug and the original drug are the same, and have the same BE as the original drug, and no longer need to pass clinical trials
.
For the first time, the bill allows generic drug manufacturers to challenge the patents of original research drug manufacturers from a regulatory approach to ensure FDA approval and market entry
.
Since then, the number of prescriptions for generic drugs in the United States has risen from less than 20% to nearly 90% in 2018
.
.
Generic drug manufacturers only need to prove that the dosage form, specifications, active ingredients, and route of administration of the generic drug and the original drug are the same, and have the same BE as the original drug, and no longer need to pass clinical trials
.
For the first time, the bill allows generic drug manufacturers to challenge the patents of original research drug manufacturers from a regulatory approach to ensure FDA approval and market entry
.
Since then, the number of prescriptions for generic drugs in the United States has risen from less than 20% to nearly 90% in 2018
.
In October 2012, in order to cope with the shortage of personnel and the backlog of approvals caused by the increasing number of generic drug applications, the US Congress passed the Generic Drug Manufacturers Fees Act (GDUFA Act), requiring pharmaceutical companies to pay the FDA for review and inspection of generic drug applications.
Facilities cost fees
.
This system has been strictly enforced by the FDA since 2015
.
While charging generic drug companies, the GDUFA Act also promises the timeliness of approval, which objectively promotes the acceleration of generic drug approval
.
The average approval period for generic drugs has been significantly shortened from nearly three years in the past.
For some products that can pass all approval procedures at one time, the limit approval period is only 9-10 months
.
Facilities cost fees
.
This system has been strictly enforced by the FDA since 2015
.
While charging generic drug companies, the GDUFA Act also promises the timeliness of approval, which objectively promotes the acceleration of generic drug approval
.
The average approval period for generic drugs has been significantly shortened from nearly three years in the past.
For some products that can pass all approval procedures at one time, the limit approval period is only 9-10 months
.
Before Japan's "promotion of the use of generic drugs" was established as a national policy in 2007, the replacement rate of generic drugs in Japan in 2005 was only 32.
5%, ranking low in developed countries and regions.
This was not the same as the Japanese medical community's understanding of generic drugs at the time.
There is a greater connection between deep and lack of confidence
.
As the Japanese government initiated a series of popularization activities from top to bottom, and actively guided the medical insurance payment policy, the replacement rate of generic drugs began to rise rapidly after 2010, reaching 39.
9% in 2011 and 72.
6% in 2019.
Basically achieve the 80% goal of the Ministry of Health, Labour and Welfare
.
Although there is still a gap compared with the high level of 90% substitution rate of generic drugs in the United States, Japan has caught up with European countries such as Italy, France and Spain
.
5%, ranking low in developed countries and regions.
This was not the same as the Japanese medical community's understanding of generic drugs at the time.
There is a greater connection between deep and lack of confidence
.
As the Japanese government initiated a series of popularization activities from top to bottom, and actively guided the medical insurance payment policy, the replacement rate of generic drugs began to rise rapidly after 2010, reaching 39.
9% in 2011 and 72.
6% in 2019.
Basically achieve the 80% goal of the Ministry of Health, Labour and Welfare
.
Although there is still a gap compared with the high level of 90% substitution rate of generic drugs in the United States, Japan has caught up with European countries such as Italy, France and Spain
.
Pharmaceutical Net, June 18th.
Under the background of the normalization of mass procurement, chemical generics companies are actively seeking to break the situation.
Some companies extend upstream and integrate development to control costs; some companies deploy first generic drugs and transform and upgrade; there is another part.
Companies actively expand overseas sales channels and develop overseas
.
Under the background of the normalization of mass procurement, chemical generics companies are actively seeking to break the situation.
Some companies extend upstream and integrate development to control costs; some companies deploy first generic drugs and transform and upgrade; there is another part.
Companies actively expand overseas sales channels and develop overseas
.
According to the newly revised " Administrative Measures for Drug Registration", categories 3 and 4 are generic drugs
.
The research and development path of domestic innovative preparations is mainly imitation, and confirmatory clinical trials are required before the registration classification is changed
.
According to the new registration scheme, generic drugs of categories 3 and 4 have the same attributes and specifications as the original drugs, so they only need to pass the bioequivalence (BE) test.
The development cycle is estimated to be 28 to 32 months
.
Compared with innovative drugs, generic drugs have a shorter R&D cycle and lower cost
.
.
The research and development path of domestic innovative preparations is mainly imitation, and confirmatory clinical trials are required before the registration classification is changed
.
According to the new registration scheme, generic drugs of categories 3 and 4 have the same attributes and specifications as the original drugs, so they only need to pass the bioequivalence (BE) test.
The development cycle is estimated to be 28 to 32 months
.
Compared with innovative drugs, generic drugs have a shorter R&D cycle and lower cost
.
At present, the proportion of American generic drugs in prescription drugs has reached about 90%, and the proportion of the amount is only about 10%; while the proportion of the amount of generic drugs in China is still more than 70%, accounting for a relatively high proportion
.
With reference to the US path, the proportion of total domestic sales of generic drugs will show a downward trend in the future
.
.
With reference to the US path, the proportion of total domestic sales of generic drugs will show a downward trend in the future
.
Extension of integrated development upstream
The Water Pollution Prevention and Control Action Plan issued by the State Council in 2015 had a profound impact on the API industry.
Many small and medium-sized API companies closed down and permanently withdrew from the market
.
According to data from the National Food and Drug Administration, China's API and preparation manufacturers reached 5,065 in 2015, but this dropped to 4,176 in 2016
.
The removal of high-polluting small and medium-sized enterprises has greatly optimized the industry competition pattern and increased industry concentration
.
Many small and medium-sized API companies closed down and permanently withdrew from the market
.
According to data from the National Food and Drug Administration, China's API and preparation manufacturers reached 5,065 in 2015, but this dropped to 4,176 in 2016
.
The removal of high-polluting small and medium-sized enterprises has greatly optimized the industry competition pattern and increased industry concentration
.
At the same time, the price of preparations purchased in quantities has dropped significantly, and the trend of vertical integration of generic pharmaceutical companies is obvious
.
According to statistics, the average price cuts of the five batches of nationally adopted generic drugs are all above 50%
.
At this time, the sales expenses, which accounted for about 40% of the old drug sales model, were almost completely squeezed, and the profitability of generic drug companies almost came from cost control and production efficiency
.
In the context of centralized procurement, the key to winning bids for companies is low cost.
Generic drug companies are expanding to the upstream field, and the development trend of industrial chain integration is obvious
.
.
According to statistics, the average price cuts of the five batches of nationally adopted generic drugs are all above 50%
.
At this time, the sales expenses, which accounted for about 40% of the old drug sales model, were almost completely squeezed, and the profitability of generic drug companies almost came from cost control and production efficiency
.
In the context of centralized procurement, the key to winning bids for companies is low cost.
Generic drug companies are expanding to the upstream field, and the development trend of industrial chain integration is obvious
.
Layout of the first generic drug transformation and upgrading
Since 2012, the annual sales of original research drugs whose patents expire each year have been between US$30 billion and US$60 billion, accounting for 4% to 7% of the global patented drug market
.
Due to the expiration of patents, the loss of the original research drug market caused by the entry of generic drugs into the market is between 15 billion and 36 billion US dollars per year
.
According to the prediction of Eval uate Phar ma, after the low patent expiration period in 2020 and 2021, there will be a new round of patent cliffs from 2022 to 2025.
The estimated market size of expired patent drugs is about 224 billion U.
S.
dollars.
.
.
Due to the expiration of patents, the loss of the original research drug market caused by the entry of generic drugs into the market is between 15 billion and 36 billion US dollars per year
.
According to the prediction of Eval uate Phar ma, after the low patent expiration period in 2020 and 2021, there will be a new round of patent cliffs from 2022 to 2025.
The estimated market size of expired patent drugs is about 224 billion U.
S.
dollars.
.
After the patent expired, both the original research drug and the generic drug experienced a cliff-edge price cut, especially after the patent expired one year after the overall decline was 51% (the decline of oral drugs was 66%)
.
At the same time, according to public data from the US FDA, competition will intensify and the price of generic drugs will decrease.
The first generic drug is about 94% of the price of the original drug.
After the second generic drug is launched, its price drops to 52% of the original drug.
The number of generic drugs continues to increase, and the decline continues to intensify.
When there are close to 20 generic drugs of the same variety, their prices have dropped to about 6% of the price of the original research drug
.
.
At the same time, according to public data from the US FDA, competition will intensify and the price of generic drugs will decrease.
The first generic drug is about 94% of the price of the original drug.
After the second generic drug is launched, its price drops to 52% of the original drug.
The number of generic drugs continues to increase, and the decline continues to intensify.
When there are close to 20 generic drugs of the same variety, their prices have dropped to about 6% of the price of the original research drug
.
Domestic high-quality generic drug companies have significant competitive advantages in the first generic drug market
.
Companies such as Hengrui, Hausen, Xinlitai, Chia Tai Tianqing, and East China Pharmaceuticals focus on high-quality generic drugs, which have been recognized and supported by a large number of institutions and clinical experts, and have established brand advantages .
Data shows that although the first generic drugs of these companies have been on the market for many years and other generic drugs have entered one after another, the market performance of these high-quality generic drug companies is still better than other generic drug companies and can maintain their share in the generic drug market .
.
Companies such as Hengrui, Hausen, Xinlitai, Chia Tai Tianqing, and East China Pharmaceuticals focus on high-quality generic drugs, which have been recognized and supported by a large number of institutions and clinical experts, and have established brand advantages .
Data shows that although the first generic drugs of these companies have been on the market for many years and other generic drugs have entered one after another, the market performance of these high-quality generic drug companies is still better than other generic drug companies and can maintain their share in the generic drug market .
Expand overseas channels and actively develop
In recent years, assisted by the domestic generic drug consistency evaluation policy, a large number of generic drug companies have survived the fittest, and are also actively exploring export markets on the premise of improving their own quality.
The number of abbreviated new drug applications (ANDA) approvals filed by Chinese pharmaceutical companies for export to the United States has continued to rise.
2018 ushered in the highest volume in history, with a total of 99 ANDA approvals obtained, of which 80 ANDA approvals have been approved, 19 are tentative approvals; in 2019, the number of ANDA approvals was 65
.
The number of abbreviated new drug applications (ANDA) approvals filed by Chinese pharmaceutical companies for export to the United States has continued to rise.
2018 ushered in the highest volume in history, with a total of 99 ANDA approvals obtained, of which 80 ANDA approvals have been approved, 19 are tentative approvals; in 2019, the number of ANDA approvals was 65
.
Huahai Pharmaceutical is a representative of the export of preparations
.
From 2015 to 2019, Huahai Pharmaceutical obtained approximately 80 ANDAs
.
While establishing an overseas marketing network and expanding overseas markets, the company has also begun to return to the local market.
Under the national centralized procurement policy, it has demonstrated its global synchronized quality system and cost control advantages in market competition
.
At the same time, the second and third echelon teams continue to grow, and the number of approvals has increased significantly.
In 2019, the new faces of Chinese companies that have been approved by the US ANDA include Hainan Shuangcheng, Zhengda Group and Jiangxi Boya
.
.
From 2015 to 2019, Huahai Pharmaceutical obtained approximately 80 ANDAs
.
While establishing an overseas marketing network and expanding overseas markets, the company has also begun to return to the local market.
Under the national centralized procurement policy, it has demonstrated its global synchronized quality system and cost control advantages in market competition
.
At the same time, the second and third echelon teams continue to grow, and the number of approvals has increased significantly.
In 2019, the new faces of Chinese companies that have been approved by the US ANDA include Hainan Shuangcheng, Zhengda Group and Jiangxi Boya
.
(Author's unit: Firestone Creation)
Further reading
Overview of the development of the U.
S.
and Japan generic drug industry
S.
and Japan generic drug industry
United States In 1984, the United States promulgated the "Drug Price Competition and Patent Term Compensation Act" (Hatch-waxman Act), which established a generic drug ANDA approach, and the amount of generic drugs gradually increased
.
Generic drug manufacturers only need to prove that the dosage form, specifications, active ingredients, and route of administration of the generic drug and the original drug are the same, and have the same BE as the original drug, and no longer need to pass clinical trials
.
For the first time, the bill allows generic drug manufacturers to challenge the patents of original research drug manufacturers from a regulatory approach to ensure FDA approval and market entry
.
Since then, the number of prescriptions for generic drugs in the United States has risen from less than 20% to nearly 90% in 2018
.
.
Generic drug manufacturers only need to prove that the dosage form, specifications, active ingredients, and route of administration of the generic drug and the original drug are the same, and have the same BE as the original drug, and no longer need to pass clinical trials
.
For the first time, the bill allows generic drug manufacturers to challenge the patents of original research drug manufacturers from a regulatory approach to ensure FDA approval and market entry
.
Since then, the number of prescriptions for generic drugs in the United States has risen from less than 20% to nearly 90% in 2018
.
In October 2012, in order to cope with the shortage of personnel and the backlog of approvals caused by the increasing number of generic drug applications, the US Congress passed the Generic Drug Manufacturers Fees Act (GDUFA Act), requiring pharmaceutical companies to pay the FDA for review and inspection of generic drug applications.
Facilities cost fees
.
This system has been strictly enforced by the FDA since 2015
.
While charging generic drug companies, the GDUFA Act also promises the timeliness of approval, which objectively promotes the acceleration of generic drug approval
.
The average approval period for generic drugs has been significantly shortened from nearly three years in the past.
For some products that can pass all approval procedures at one time, the limit approval period is only 9-10 months
.
Facilities cost fees
.
This system has been strictly enforced by the FDA since 2015
.
While charging generic drug companies, the GDUFA Act also promises the timeliness of approval, which objectively promotes the acceleration of generic drug approval
.
The average approval period for generic drugs has been significantly shortened from nearly three years in the past.
For some products that can pass all approval procedures at one time, the limit approval period is only 9-10 months
.
Before Japan's "promotion of the use of generic drugs" was established as a national policy in 2007, the replacement rate of generic drugs in Japan in 2005 was only 32.
5%, ranking low in developed countries and regions.
This was not the same as the Japanese medical community's understanding of generic drugs at the time.
There is a greater connection between deep and lack of confidence
.
As the Japanese government initiated a series of popularization activities from top to bottom, and actively guided the medical insurance payment policy, the replacement rate of generic drugs began to rise rapidly after 2010, reaching 39.
9% in 2011 and 72.
6% in 2019.
Basically achieve the 80% goal of the Ministry of Health, Labour and Welfare
.
Although there is still a gap compared with the high level of 90% substitution rate of generic drugs in the United States, Japan has caught up with European countries such as Italy, France and Spain
.
5%, ranking low in developed countries and regions.
This was not the same as the Japanese medical community's understanding of generic drugs at the time.
There is a greater connection between deep and lack of confidence
.
As the Japanese government initiated a series of popularization activities from top to bottom, and actively guided the medical insurance payment policy, the replacement rate of generic drugs began to rise rapidly after 2010, reaching 39.
9% in 2011 and 72.
6% in 2019.
Basically achieve the 80% goal of the Ministry of Health, Labour and Welfare
.
Although there is still a gap compared with the high level of 90% substitution rate of generic drugs in the United States, Japan has caught up with European countries such as Italy, France and Spain
.
Pharmaceutical Net, June 18th.
Under the background of the normalization of mass procurement, chemical generics companies are actively seeking to break the situation.
Some companies extend upstream and integrate development to control costs; some companies deploy first generic drugs and transform and upgrade; there is another part.
Companies actively expand overseas sales channels and develop overseas
.
Under the background of the normalization of mass procurement, chemical generics companies are actively seeking to break the situation.
Some companies extend upstream and integrate development to control costs; some companies deploy first generic drugs and transform and upgrade; there is another part.
Companies actively expand overseas sales channels and develop overseas
.
According to the newly revised " Administrative Measures for Drug Registration", categories 3 and 4 are generic drugs
.
The research and development path of domestic innovative preparations is mainly imitation, and confirmatory clinical trials are required before the registration classification is changed
.
According to the new registration scheme, generic drugs of categories 3 and 4 have the same attributes and specifications as the original drugs, so they only need to pass the bioequivalence (BE) test.
The development cycle is estimated to be 28 to 32 months
.
Compared with innovative drugs, generic drugs have a shorter R&D cycle and lower cost
.
Medicine, medicine, medicine.
The research and development path of domestic innovative preparations is mainly imitation, and confirmatory clinical trials are required before the registration classification is changed
.
According to the new registration scheme, generic drugs of categories 3 and 4 have the same attributes and specifications as the original drugs, so they only need to pass the bioequivalence (BE) test.
The development cycle is estimated to be 28 to 32 months
.
Compared with innovative drugs, generic drugs have a shorter R&D cycle and lower cost
.
At present, the proportion of American generic drugs in prescription drugs has reached about 90%, and the proportion of the amount is only about 10%; while the proportion of the amount of generic drugs in China is still more than 70%, accounting for a relatively high proportion
.
With reference to the US path, the proportion of total domestic sales of generic drugs will show a downward trend in the future
.
.
With reference to the US path, the proportion of total domestic sales of generic drugs will show a downward trend in the future
.
Extension of integrated development upstream
Extension of integrated development upstream The Water Pollution Prevention and Control Action Plan issued by the State Council in 2015 had a profound impact on the API industry.
Many small and medium-sized API companies closed down and permanently withdrew from the market
.
According to data from the National Food and Drug Administration, China's API and preparation manufacturers reached 5,065 in 2015, but this dropped to 4,176 in 2016
.
The removal of high-polluting small and medium-sized enterprises has greatly optimized the industry competition pattern and increased industry concentration
.
Many small and medium-sized API companies closed down and permanently withdrew from the market
.
According to data from the National Food and Drug Administration, China's API and preparation manufacturers reached 5,065 in 2015, but this dropped to 4,176 in 2016
.
The removal of high-polluting small and medium-sized enterprises has greatly optimized the industry competition pattern and increased industry concentration
.
At the same time, the price of preparations purchased in quantities has dropped significantly, and the trend of vertical integration of generic pharmaceutical companies is obvious
.
According to statistics, the average price cuts of the five batches of nationally adopted generic drugs are all above 50%
.
At this time, the sales expenses, which accounted for about 40% of the old drug sales model, were almost completely squeezed, and the profitability of generic drug companies almost came from cost control and production efficiency
.
In the context of centralized procurement, the key to winning bids for companies is low cost.
Generic drug companies are expanding to the upstream field, and the development trend of industrial chain integration is obvious
.
Procurement Purchasing Procurement.
According to statistics, the average price cuts of the five batches of nationally adopted generic drugs are all above 50%
.
At this time, the sales expenses, which accounted for about 40% of the old drug sales model, were almost completely squeezed, and the profitability of generic drug companies almost came from cost control and production efficiency
.
In the context of centralized procurement, the key to winning bids for companies is low cost.
Generic drug companies are expanding to the upstream field, and the development trend of industrial chain integration is obvious
.
Layout of the first generic drug transformation and upgrading
Layout of the first generic drug transformation and upgrading Since 2012, the annual sales of original research drugs whose patents expire each year have been between US$30 billion and US$60 billion, accounting for 4% to 7% of the global patented drug market
.
Due to the expiration of patents, the loss of the original research drug market caused by the entry of generic drugs into the market is between 15 billion and 36 billion US dollars per year
.
According to the prediction of Eval uate Phar ma, after the low patent expiration period in 2020 and 2021, there will be a new round of patent cliffs from 2022 to 2025.
The estimated market size of expired patent drugs is about 224 billion U.
S.
dollars.
.
.
Due to the expiration of patents, the loss of the original research drug market caused by the entry of generic drugs into the market is between 15 billion and 36 billion US dollars per year
.
According to the prediction of Eval uate Phar ma, after the low patent expiration period in 2020 and 2021, there will be a new round of patent cliffs from 2022 to 2025.
The estimated market size of expired patent drugs is about 224 billion U.
S.
dollars.
.
After the patent expired, both the original research drug and the generic drug experienced a cliff-edge price cut, especially after the patent expired one year after the overall decline was 51% (the decline of oral drugs was 66%)
.
At the same time, according to public data from the US FDA, competition will intensify and the price of generic drugs will decrease.
The first generic drug is about 94% of the price of the original drug.
After the second generic drug is launched, its price drops to 52% of the original drug.
The number of generic drugs continues to increase, and the decline continues to intensify.
When there are close to 20 generic drugs of the same variety, their prices have dropped to about 6% of the price of the original research drug
.
.
At the same time, according to public data from the US FDA, competition will intensify and the price of generic drugs will decrease.
The first generic drug is about 94% of the price of the original drug.
After the second generic drug is launched, its price drops to 52% of the original drug.
The number of generic drugs continues to increase, and the decline continues to intensify.
When there are close to 20 generic drugs of the same variety, their prices have dropped to about 6% of the price of the original research drug
.
Domestic high-quality generic drug companies have significant competitive advantages in the first generic drug market
.
Companies such as Hengrui, Hausen, Xinlitai, Chia Tai Tianqing, and East China Pharmaceuticals focus on high-quality generic drugs, which have been recognized and supported by a large number of institutions and clinical experts, and have established brand advantages .
Data shows that although the first generic drugs of these companies have been on the market for many years and other generic drugs have entered one after another, the market performance of these high-quality generic drug companies is still better than other generic drug companies and can maintain their share in the generic drug market .
Pharmaceutical Pharmaceutical Pharmaceutical Enterprise Enterprise Enterprise.
Companies such as Hengrui, Hausen, Xinlitai, Chia Tai Tianqing, and East China Pharmaceuticals focus on high-quality generic drugs, which have been recognized and supported by a large number of institutions and clinical experts, and have established brand advantages .
Data shows that although the first generic drugs of these companies have been on the market for many years and other generic drugs have entered one after another, the market performance of these high-quality generic drug companies is still better than other generic drug companies and can maintain their share in the generic drug market .
Expand overseas channels and actively develop
Expand overseas channels and actively develop In recent years, assisted by the domestic generic drug consistency evaluation policy, a large number of generic drug companies have survived the fittest, and are also actively exploring export markets on the premise of improving their own quality.
The number of abbreviated new drug applications (ANDA) approvals filed by Chinese pharmaceutical companies for export to the United States has continued to rise.
2018 ushered in the highest volume in history, with a total of 99 ANDA approvals obtained, of which 80 ANDA approvals have been approved, 19 are tentative approvals; in 2019, the number of ANDA approvals was 65
.
The number of abbreviated new drug applications (ANDA) approvals filed by Chinese pharmaceutical companies for export to the United States has continued to rise.
2018 ushered in the highest volume in history, with a total of 99 ANDA approvals obtained, of which 80 ANDA approvals have been approved, 19 are tentative approvals; in 2019, the number of ANDA approvals was 65
.
Huahai Pharmaceutical is a representative of the export of preparations
.
From 2015 to 2019, Huahai Pharmaceutical obtained approximately 80 ANDAs
.
While establishing an overseas marketing network and expanding overseas markets, the company has also begun to return to the local market.
Under the national centralized procurement policy, it has demonstrated its global synchronized quality system and cost control advantages in market competition
.
At the same time, the second and third echelon teams continue to grow, and the number of approvals has increased significantly.
In 2019, the new faces of Chinese companies that have been approved by the US ANDA include Hainan Shuangcheng, Zhengda Group and Jiangxi Boya
.
.
From 2015 to 2019, Huahai Pharmaceutical obtained approximately 80 ANDAs
.
While establishing an overseas marketing network and expanding overseas markets, the company has also begun to return to the local market.
Under the national centralized procurement policy, it has demonstrated its global synchronized quality system and cost control advantages in market competition
.
At the same time, the second and third echelon teams continue to grow, and the number of approvals has increased significantly.
In 2019, the new faces of Chinese companies that have been approved by the US ANDA include Hainan Shuangcheng, Zhengda Group and Jiangxi Boya
.
(Author's unit: Firestone Creation)
(Author's unit: Firestone Creation) Further reading
Further reading Overview of the development of the U.
S.
and Japan generic drug industry
Overview of the development of the U. S.
and Japan generic drug industry
S.
and Japan generic drug industry
United States In 1984, the United States promulgated the "Drug Price Competition and Patent Term Compensation Act" (Hatch-waxman Act), which established a generic drug ANDA approach, and the amount of generic drugs gradually increased
.
Generic drug manufacturers only need to prove that the dosage form, specifications, active ingredients, and route of administration of the generic drug and the original drug are the same, and have the same BE as the original drug, and no longer need to pass clinical trials
.
For the first time, the bill allows generic drug manufacturers to challenge the patents of original research drug manufacturers from a regulatory approach to ensure FDA approval and market entry
.
Since then, the number of prescriptions for generic drugs in the United States has risen from less than 20% to nearly 90% in 2018
.
.
Generic drug manufacturers only need to prove that the dosage form, specifications, active ingredients, and route of administration of the generic drug and the original drug are the same, and have the same BE as the original drug, and no longer need to pass clinical trials
.
For the first time, the bill allows generic drug manufacturers to challenge the patents of original research drug manufacturers from a regulatory approach to ensure FDA approval and market entry
.
Since then, the number of prescriptions for generic drugs in the United States has risen from less than 20% to nearly 90% in 2018
.
In October 2012, in order to cope with the shortage of personnel and the backlog of approvals caused by the increasing number of generic drug applications, the US Congress passed the Generic Drug Manufacturers Fees Act (GDUFA Act), requiring pharmaceutical companies to pay the FDA for review and inspection of generic drug applications.
Facilities cost fees
.
This system has been strictly enforced by the FDA since 2015
.
While charging generic drug companies, the GDUFA Act also promises the timeliness of approval, which objectively promotes the acceleration of generic drug approval
.
The average approval period for generic drugs has been significantly shortened from nearly three years in the past.
For some products that can pass all approval procedures at one time, the limit approval period is only 9-10 months
.
Facilities cost fees
.
This system has been strictly enforced by the FDA since 2015
.
While charging generic drug companies, the GDUFA Act also promises the timeliness of approval, which objectively promotes the acceleration of generic drug approval
.
The average approval period for generic drugs has been significantly shortened from nearly three years in the past.
For some products that can pass all approval procedures at one time, the limit approval period is only 9-10 months
.
Before Japan's "promotion of the use of generic drugs" was established as a national policy in 2007, the replacement rate of generic drugs in Japan in 2005 was only 32.
5%, ranking low in developed countries and regions.
This was not the same as the Japanese medical community's understanding of generic drugs at the time.
There is a greater connection between deep and lack of confidence
.
As the Japanese government initiated a series of popularization activities from top to bottom, and actively guided the medical insurance payment policy, the replacement rate of generic drugs began to rise rapidly after 2010, reaching 39.
9% in 2011 and 72.
6% in 2019.
Basically achieve the 80% goal of the Ministry of Health, Labour and Welfare
.
Although there is still a gap compared with the high level of 90% substitution rate of generic drugs in the United States, Japan has caught up with European countries such as Italy, France and Spain
.
5%, ranking low in developed countries and regions.
This was not the same as the Japanese medical community's understanding of generic drugs at the time.
There is a greater connection between deep and lack of confidence
.
As the Japanese government initiated a series of popularization activities from top to bottom, and actively guided the medical insurance payment policy, the replacement rate of generic drugs began to rise rapidly after 2010, reaching 39.
9% in 2011 and 72.
6% in 2019.
Basically achieve the 80% goal of the Ministry of Health, Labour and Welfare
.
Although there is still a gap compared with the high level of 90% substitution rate of generic drugs in the United States, Japan has caught up with European countries such as Italy, France and Spain
.
