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Recently, undercurrents in the field of biosimilar drugs have been surging
.
Looking into the distance, the Korean pharmaceutical company Celltrion announced that its rituximab biosimilar Truxima had a combined market share of 46% in the UK, France, Italy, Germany and Spain as of the second quarter of this year.
These five countries have approximately It accounts for 70% of the European rituximab market
.
From the perspective of the entire European market, the drug's share has exceeded 40%, and another original drug in the European market has been overtaken by similar drugs
.
Taking a closer look at the domestic market, the competition situation has become more intense
.
Taking bevacizumab as an example, biosimilars are in full bloom and have formed a "1+6" pattern: Bevacizumab's biosimilar has just been approved
.
Earlier, Roche's bevacizumab was approved for two new indications for gynecological tumors, and Biotec's bevacizumab biosimilar was approved for two indications for non-small cell lung cancer and colorectal cancer
.
In the first half of this year, among the top 10 Western medicines sold in public hospitals in key provinces and cities, Qilu’s bevacizumab has the fastest growth rate, and its market share has surpassed The original research drug, plus more than 20 companies such as Fuhong Henlius and Corning Jerry are still racing in this field, and the competition is extremely fierce
.
This shows that biosimilars have risen strongly around the world, especially in China
.
At present, the blockbuster biopharmaceuticals that are popular in clinical practice are facing the full impact of their similar drugs
.
Rituximab biosimilar drugs surpassed the original research drug in Europe
.
In China, after the rituximab biosimilar of Fuhong Hanlius was approved for marketing in China in 2019, the first domestically produced biosimilar broke the market monopoly of the original drug for more than ten years
.
Cinda subsequently followed up, and there are more than 10 related clinical trials, and 7 of them are in clinical phase III or above
.
The resulting situation is that as of the first half of this year, the first rituximab biosimilar drug has completed the medical insurance opening of 30 domestic provinces and cities, and more than 70% of core hospitals have realized the purchase of drugs.
In 2020, the domestic sales will be rapid.
Growth, while sales of the original research drug Rituxan in China declined by 23%
.
Not only that, the global competition for rituximab has become more intense
.
In the European market where biosimilars are the most mature, the first approved rituximab biosimilar has surpassed the original research drug
.
Analyzing the European substitution curve, it can be seen that the first biosimilar drug accounted for more than 40% of the market share (including original research drugs and biosimilar drugs) in an average of 5 years after it was launched
.
On average, in the European biopharmaceutical market, the first biosimilar to be marketed has a first-mover advantage, and Truxima has enriched this curve with the latest data
.
The first domestic rituximab biosimilar drug is also deployed in Latin American countries such as Colombia, Peru, Ecuador and Venezuela, and the global competition for biologic drugs is more adequate
.
Bevacizumab is also a biological drug in the same situation
.
As of November of this year, among the 31 biosimilar drugs approved by the FDA, bevacizumab-like drugs are particularly eye-catching.
The newly approved Mvasi and Zirabev: the former will be officially sold in the United States after the Avastin patent expires in 2019, and is the second in the market.
Earned 798 million U.
S.
dollars in revenue in 2009; the latter’s sales in the first year of 2020 reached 143 million U.
S.
dollars.
These similar drugs have brought tremendous competitive pressure to original research drugs
.
Table 1 In the first half of the first half of the year, the data of the top 10 drugs sold in public hospitals in key provinces and cities come from: The Minai.
net database is in China.
Among the bevacizumabs that have been on the market, the original research drug and Qilu's biosimilar drugs have their own advantages.
In the initial stage, the market share is low
.
From the perspective of trends, latecomers may break through through the differentiation strategy of indications.
For example, Betta and Henlius have selected the indications for metastatic colorectal cancer, which is different from the current domestically marketed bevacizumab biosimilar drugs; or It is an extension to overseas.
For example, Cinda has actively deployed overseas rights and interests in the United States, Canada and Indonesia.
.
Biotech cooperated with Novartis subsidiary Sandoz to conditionally expand bevacizumab-like drugs in international markets such as Europe, America and Canada, and a comprehensive multi-dimensional competition pattern is on the verge
.
As far as adalimumab is concerned, AbbVie's global sales of Humira have been increasing in recent years, but its domestic sales have gradually declined, and the sales scale is much lower than that of the European and American markets, and there is also great potential for substitution
.
Companies such as Biotech and Hisun have taken the lead, and 46 clinical trials are still in progress
.
Major biological drugs including adalimumab are accelerating their differentiation.
With the price gap gradually narrowing, indications have become the key to victory.
At present, adalimumab has few domestic indications, so biological analogues are in this event.
The “Law of the Jungle” was outstanding in the contest
.
Increasing homogeneity, market substitution speed Although bio-similar drugs attract attention, it is not a feast of equal opportunities
.
If we focus on this competitive landscape in the Chinese market and observe it, striving for one and protecting two and seeing three and four from a long-term perspective will be the fortress of competition in the future
.
First of all, the clinical application of biosimilars has gradually been recognized
.
CDE’s “Guiding Principles for the Evaluation of Similarity of Biosimilars and the Extrapolation of Indications” emphasizes that through scientific demonstration of the research data and information related to the indications to be extrapolated, it is supported to be used as a reference drug that has not been directly approved by China.
Research indications
.
Under this circumstance, biosimilars need to differentiate their indication strategies and the comparative advantages of R&D speed to flex their muscles
.
Similar drugs have an average market share of 44.
1% in Europe, and latecomers are slightly weak in seizing the market
.
For example, after Flixabi, Remicade’s second biosimilar drug approved by the EMA, entered the European market, after competing with the original research and the first biosimilar drug, it grabbed 0.
7% of the market share in the first year and market share in the second year.
Increased to 3.
4%, but less than 1/3 of the market share of the original research drug in the second year of its launch
.
If so, the domestic biopharmaceutical market will also face the same test
.
Figure 1 Data on the number of clinical trials for different targets comes from: "Annual Report on the Current Status of Clinical Trials for New Drug Registration in China" There are 2602 domestic drug clinical trials in 2020, an increase of 9.
1% over the previous year, and domestic sponsors accounted for more than 70%.
Among the 10 targets, drugs with 9 targets are concentrated on the same indication, and more than 90% of the indications for 7 target drugs are concentrated in the field of anti-tumor
.
This shows that behind the innovation and prosperity of oncology drugs, who can be approved for listing first is related to the success or failure of the market
.
Those who are struggling to meet new challenges in reality first: The recruitment of subjects is becoming a key element that affects the speed of clinical trials
.
At present, more than 60 clinical trials have been carried out for target varieties such as PD-1 and VEGFR; in addition, the proportion of phase I clinical trials of 6 target drugs is more than 40%, and the phase II clinical trials are in each target point.
The proportions of PD-1 and VEGFR are not high, and there are as many as 20 Phase III clinical trials of targets such as PD-1 and VEGFR
.
Table 2 The data on the distribution of the number of people enrolled in clinical trials are from: "Annual Report on the Current Status of Clinical Trials in New Drug Registration in China" Officially disclosed that in the clinical trials registered in 2020, less than half of the recruiting participants will be initiated within one year after the clinical trial is approved ( 45.
4%); the clinical trials completed in 2020 will still be phase I clinical trials, and the drug clinical trials in 2020 will still be dominated by domestic clinical trials, accounting for 91.
6%, and international multi-center trials only accounting for 8.
1%, including Domestic competition, including biosimilar drugs, will be more intense
.
At present, clinical studies of the above-mentioned hot-selling similar drugs such as bevacizumab and trastuzumab are all extending overseas
.
However, for single-center clinical trials that do not recruit subjects in China or are only conducted abroad, the proportion is only 0.
3%; the proportion of international multi-center trials is relatively high, at 14.
1%
.
Many companies have reported that “the time cost and opportunity cost of clinical trials are increasing
.
” The shortage of resources for subjects will inevitably affect the speed and space of the project.
.
Cost advantage wins and maximizes coverage.
Although there are still different views on the clinical application of biosimilar drugs, and although it has been confirmed that there is no significant difference in the safety and effectiveness of biological drugs and original biologic drugs, objectively speaking, the clinical application of drugs Research on exchanges still needs to be strengthened overall
.
The limited clinical evidence also affects the attitude of clinical medication
.
Some experts suggest that policies should encourage companies to report patient safety and immunogenicity data in different conversion scenarios for post-marketing biosimilars and original biologics
.
Moreover, after the completion of the purchase of insulin, the expansion of biopharmaceuticals will definitely increase
.
Therefore, after the product goes on the market, the cost advantage and product coverage capability have to be tested
.
It will be a general trend to fight for cost advantages while ensuring high quality
.
Recently, Merck has used its advantages in antibody enhancement technology, continuous process equipment, and economically suitable medium development, and cooperated with Boan Biotech’s platform technology and industrial chain to further enhance its production efficiency and optimize production costs.
This kind of cooperation far exceeds the commercial value of a single product
.
Boan Biological’s bevacizumab biosimilar drug "precedes tigers and pursues soldiers".
Its commercial strategy is to choose to cooperate with AstraZeneca in addition to building its own commercial team and authorize the latter to operate 21 in China The exclusive promotion of the drug in the counties of provinces, municipalities, and districts, and the maximization of product coverage through resource synergy, is an important entry point in the competitive strategy of biosimilars
.
Biotech also knows this well
.
At the beginning of this year, Renpain cut down two ADC drug research and development projects in a row and focused on weight-loss actions.
Its 2021 mid-term report showed that among the 13 drugs under research, bevacizumab, tocilizumab, skucilizumab and The cumulative R&D investment of four biosimilar drugs of Golimumab reached 1.
13 billion yuan, accounting for nearly 75% of the total R&D costs.
Biotech hopes to be the best in class among the mature varieties of the target
.
In August last year, it gave BeiGene the commercialization rights of bevacizumab in China to seek greater channel coverage.
Whether it can break out of the "jungle" remains to be tested by the market
.
With the sustainable development of multinational corporations in China, they gradually strengthen their localization with China as the center, while the sustainable development of Chinese innovative companies is also gradually internationalization, and the competition between biopharmaceuticals will become more complicated.
With products It also tests the overall strength of the enterprise
.
.
Looking into the distance, the Korean pharmaceutical company Celltrion announced that its rituximab biosimilar Truxima had a combined market share of 46% in the UK, France, Italy, Germany and Spain as of the second quarter of this year.
These five countries have approximately It accounts for 70% of the European rituximab market
.
From the perspective of the entire European market, the drug's share has exceeded 40%, and another original drug in the European market has been overtaken by similar drugs
.
Taking a closer look at the domestic market, the competition situation has become more intense
.
Taking bevacizumab as an example, biosimilars are in full bloom and have formed a "1+6" pattern: Bevacizumab's biosimilar has just been approved
.
Earlier, Roche's bevacizumab was approved for two new indications for gynecological tumors, and Biotec's bevacizumab biosimilar was approved for two indications for non-small cell lung cancer and colorectal cancer
.
In the first half of this year, among the top 10 Western medicines sold in public hospitals in key provinces and cities, Qilu’s bevacizumab has the fastest growth rate, and its market share has surpassed The original research drug, plus more than 20 companies such as Fuhong Henlius and Corning Jerry are still racing in this field, and the competition is extremely fierce
.
This shows that biosimilars have risen strongly around the world, especially in China
.
At present, the blockbuster biopharmaceuticals that are popular in clinical practice are facing the full impact of their similar drugs
.
Rituximab biosimilar drugs surpassed the original research drug in Europe
.
In China, after the rituximab biosimilar of Fuhong Hanlius was approved for marketing in China in 2019, the first domestically produced biosimilar broke the market monopoly of the original drug for more than ten years
.
Cinda subsequently followed up, and there are more than 10 related clinical trials, and 7 of them are in clinical phase III or above
.
The resulting situation is that as of the first half of this year, the first rituximab biosimilar drug has completed the medical insurance opening of 30 domestic provinces and cities, and more than 70% of core hospitals have realized the purchase of drugs.
In 2020, the domestic sales will be rapid.
Growth, while sales of the original research drug Rituxan in China declined by 23%
.
Not only that, the global competition for rituximab has become more intense
.
In the European market where biosimilars are the most mature, the first approved rituximab biosimilar has surpassed the original research drug
.
Analyzing the European substitution curve, it can be seen that the first biosimilar drug accounted for more than 40% of the market share (including original research drugs and biosimilar drugs) in an average of 5 years after it was launched
.
On average, in the European biopharmaceutical market, the first biosimilar to be marketed has a first-mover advantage, and Truxima has enriched this curve with the latest data
.
The first domestic rituximab biosimilar drug is also deployed in Latin American countries such as Colombia, Peru, Ecuador and Venezuela, and the global competition for biologic drugs is more adequate
.
Bevacizumab is also a biological drug in the same situation
.
As of November of this year, among the 31 biosimilar drugs approved by the FDA, bevacizumab-like drugs are particularly eye-catching.
The newly approved Mvasi and Zirabev: the former will be officially sold in the United States after the Avastin patent expires in 2019, and is the second in the market.
Earned 798 million U.
S.
dollars in revenue in 2009; the latter’s sales in the first year of 2020 reached 143 million U.
S.
dollars.
These similar drugs have brought tremendous competitive pressure to original research drugs
.
Table 1 In the first half of the first half of the year, the data of the top 10 drugs sold in public hospitals in key provinces and cities come from: The Minai.
net database is in China.
Among the bevacizumabs that have been on the market, the original research drug and Qilu's biosimilar drugs have their own advantages.
In the initial stage, the market share is low
.
From the perspective of trends, latecomers may break through through the differentiation strategy of indications.
For example, Betta and Henlius have selected the indications for metastatic colorectal cancer, which is different from the current domestically marketed bevacizumab biosimilar drugs; or It is an extension to overseas.
For example, Cinda has actively deployed overseas rights and interests in the United States, Canada and Indonesia.
.
Biotech cooperated with Novartis subsidiary Sandoz to conditionally expand bevacizumab-like drugs in international markets such as Europe, America and Canada, and a comprehensive multi-dimensional competition pattern is on the verge
.
As far as adalimumab is concerned, AbbVie's global sales of Humira have been increasing in recent years, but its domestic sales have gradually declined, and the sales scale is much lower than that of the European and American markets, and there is also great potential for substitution
.
Companies such as Biotech and Hisun have taken the lead, and 46 clinical trials are still in progress
.
Major biological drugs including adalimumab are accelerating their differentiation.
With the price gap gradually narrowing, indications have become the key to victory.
At present, adalimumab has few domestic indications, so biological analogues are in this event.
The “Law of the Jungle” was outstanding in the contest
.
Increasing homogeneity, market substitution speed Although bio-similar drugs attract attention, it is not a feast of equal opportunities
.
If we focus on this competitive landscape in the Chinese market and observe it, striving for one and protecting two and seeing three and four from a long-term perspective will be the fortress of competition in the future
.
First of all, the clinical application of biosimilars has gradually been recognized
.
CDE’s “Guiding Principles for the Evaluation of Similarity of Biosimilars and the Extrapolation of Indications” emphasizes that through scientific demonstration of the research data and information related to the indications to be extrapolated, it is supported to be used as a reference drug that has not been directly approved by China.
Research indications
.
Under this circumstance, biosimilars need to differentiate their indication strategies and the comparative advantages of R&D speed to flex their muscles
.
Similar drugs have an average market share of 44.
1% in Europe, and latecomers are slightly weak in seizing the market
.
For example, after Flixabi, Remicade’s second biosimilar drug approved by the EMA, entered the European market, after competing with the original research and the first biosimilar drug, it grabbed 0.
7% of the market share in the first year and market share in the second year.
Increased to 3.
4%, but less than 1/3 of the market share of the original research drug in the second year of its launch
.
If so, the domestic biopharmaceutical market will also face the same test
.
Figure 1 Data on the number of clinical trials for different targets comes from: "Annual Report on the Current Status of Clinical Trials for New Drug Registration in China" There are 2602 domestic drug clinical trials in 2020, an increase of 9.
1% over the previous year, and domestic sponsors accounted for more than 70%.
Among the 10 targets, drugs with 9 targets are concentrated on the same indication, and more than 90% of the indications for 7 target drugs are concentrated in the field of anti-tumor
.
This shows that behind the innovation and prosperity of oncology drugs, who can be approved for listing first is related to the success or failure of the market
.
Those who are struggling to meet new challenges in reality first: The recruitment of subjects is becoming a key element that affects the speed of clinical trials
.
At present, more than 60 clinical trials have been carried out for target varieties such as PD-1 and VEGFR; in addition, the proportion of phase I clinical trials of 6 target drugs is more than 40%, and the phase II clinical trials are in each target point.
The proportions of PD-1 and VEGFR are not high, and there are as many as 20 Phase III clinical trials of targets such as PD-1 and VEGFR
.
Table 2 The data on the distribution of the number of people enrolled in clinical trials are from: "Annual Report on the Current Status of Clinical Trials in New Drug Registration in China" Officially disclosed that in the clinical trials registered in 2020, less than half of the recruiting participants will be initiated within one year after the clinical trial is approved ( 45.
4%); the clinical trials completed in 2020 will still be phase I clinical trials, and the drug clinical trials in 2020 will still be dominated by domestic clinical trials, accounting for 91.
6%, and international multi-center trials only accounting for 8.
1%, including Domestic competition, including biosimilar drugs, will be more intense
.
At present, clinical studies of the above-mentioned hot-selling similar drugs such as bevacizumab and trastuzumab are all extending overseas
.
However, for single-center clinical trials that do not recruit subjects in China or are only conducted abroad, the proportion is only 0.
3%; the proportion of international multi-center trials is relatively high, at 14.
1%
.
Many companies have reported that “the time cost and opportunity cost of clinical trials are increasing
.
” The shortage of resources for subjects will inevitably affect the speed and space of the project.
.
Cost advantage wins and maximizes coverage.
Although there are still different views on the clinical application of biosimilar drugs, and although it has been confirmed that there is no significant difference in the safety and effectiveness of biological drugs and original biologic drugs, objectively speaking, the clinical application of drugs Research on exchanges still needs to be strengthened overall
.
The limited clinical evidence also affects the attitude of clinical medication
.
Some experts suggest that policies should encourage companies to report patient safety and immunogenicity data in different conversion scenarios for post-marketing biosimilars and original biologics
.
Moreover, after the completion of the purchase of insulin, the expansion of biopharmaceuticals will definitely increase
.
Therefore, after the product goes on the market, the cost advantage and product coverage capability have to be tested
.
It will be a general trend to fight for cost advantages while ensuring high quality
.
Recently, Merck has used its advantages in antibody enhancement technology, continuous process equipment, and economically suitable medium development, and cooperated with Boan Biotech’s platform technology and industrial chain to further enhance its production efficiency and optimize production costs.
This kind of cooperation far exceeds the commercial value of a single product
.
Boan Biological’s bevacizumab biosimilar drug "precedes tigers and pursues soldiers".
Its commercial strategy is to choose to cooperate with AstraZeneca in addition to building its own commercial team and authorize the latter to operate 21 in China The exclusive promotion of the drug in the counties of provinces, municipalities, and districts, and the maximization of product coverage through resource synergy, is an important entry point in the competitive strategy of biosimilars
.
Biotech also knows this well
.
At the beginning of this year, Renpain cut down two ADC drug research and development projects in a row and focused on weight-loss actions.
Its 2021 mid-term report showed that among the 13 drugs under research, bevacizumab, tocilizumab, skucilizumab and The cumulative R&D investment of four biosimilar drugs of Golimumab reached 1.
13 billion yuan, accounting for nearly 75% of the total R&D costs.
Biotech hopes to be the best in class among the mature varieties of the target
.
In August last year, it gave BeiGene the commercialization rights of bevacizumab in China to seek greater channel coverage.
Whether it can break out of the "jungle" remains to be tested by the market
.
With the sustainable development of multinational corporations in China, they gradually strengthen their localization with China as the center, while the sustainable development of Chinese innovative companies is also gradually internationalization, and the competition between biopharmaceuticals will become more complicated.
With products It also tests the overall strength of the enterprise
.
