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Since the State Council policy briefing on the afternoon of January 29, it has been stated that "the inclusion of biosimilar drugs in centralized procurement is beyond doubt.
As of March 19, 2021, there are 4 monoclonal antibody biosimilars approved in China.
Table 1 China's approved monoclonal antibody biosimilar drugs and their original research products
Biosimilars gradually carve up the original research market
Biosimilars gradually carve up the original research marketFigure 1 to Figure 4 shows the changes in the proportion of purchase amount of the four biosimilar drugs approved in China from 2019Q1 to 2020Q4 in Shanghai regional hospitals ("Dabohua", "Su Lixin", "Handayuan" 3 models Since the product has only been approved recently, the procurement data of Shanghai Hospital has not yet been monitored).
Compared with the number of approved manufacturers of analogs, its approval time seems to have a greater impact on the market share of the original research.
Figure 1 Adalimumab antigen research and biosimilar drugs Proportion of hospital purchases in Shanghai (%)
Note: 2019Q2-Q4 "Humile" has no purchase data may be due to the high price and low consumption of adalimumab before the medical insurance, and no normal supply
Figure 2 Proportion of the purchase amount of bevacizumab single antigen research and biosimilar drugs in Shanghai hospitals (%)
Figure 3 Proportion of rituximab antigen research and biosimilar drugs purchased by hospitals in Shanghai (%)
Figure 4 Proportion of purchase amount of trastuzumab antigen research and biosimilar drugs in Shanghai area hospitals (%)
Biosimilars are more inclined to the grassroots market
Biosimilars are more inclined to the grassroots marketFigure 4 to Figure 8 shows the proportion of the purchase amount of the above four generic names in hospitals at all levels in Shanghai from 2019Q1 to 2020Q4.
Figure 5 Distribution of purchase amount of Adalimidine antigen research and biosimilar drugs in hospitals at all levels in Shanghai (%)
Figure 6 Distribution of purchase amount of bevacizumab single antigen research and biosimilar drugs in hospitals at all levels in Shanghai (%)
Figure 7 Distribution of purchase amount of Rituxan antigen research and biosimilar drugs in hospitals at all levels in Shanghai (%)
Figure 8 Distribution of purchase amount of trastuzumab antigen research and biosimilar drugs in hospitals at all levels in Shanghai (%)
The biosimilar prescription department follows the original research route
The biosimilar prescription department follows the original research routeFigures 9-11 show the proportion of adalimumab, bevacizumab, and rituximab prescription amounts in each department of the sample hospital in Shanghai from 2019Q1 to 2020Q4 (trastuzumab analogues have just entered the market.
Although following all the way, from these data, we can see two "careful mechanisms" for analogs to "seeking common ground while reserving differences": 1) The original prescriptions are distributed in outpatient and ward rooms, while the prescriptions for analogs are basically derived from Ward: "Han Likang" has more than 96% of the prescription amount contributed by the ward.
Figure 9 The proportion of the prescription amount of Adalimidine antigen research and biosimilar drugs in each department of Shanghai sample hospital (%)
Figure 10 Proportion of prescription amount of bevacizumab single antigen research and biosimilar drugs in each department of Shanghai sample hospital (%)
Figure 11 The proportion of the prescription amount of rituximab antigen research and biosimilar drugs in each department of Shanghai sample hospital (%)
Biologicalsimilar drugs prescription indication tendency original research
Biologicalsimilar drugs prescription indication tendency original researchFigures 12-14 show the proportion of prescription amounts for Adalimumab, Bevacizumab, and Rituximab in sample hospitals in Shanghai from 2019Q1 to 2020Q4 for each indication.
The original research and analogues of drugs used for super-indications will not only get involved in diseases that have been approved in the United States, but also diseases that have not been approved in the United States.
Figure 12 Proportion of the prescription amount of adalimin antigen research and biosimilar drugs in each indication in Shanghai sample hospitals (%)
Note: The indications with "¥" after the name of the indication represent the indications that have been approved in China and the United States, and the indications with "$" represent the indications that are only approved in the United States
Figure 13 The proportion of the prescription amount of bevacizumab single antigen research and biosimilar drugs in each indication in Shanghai sample hospitals (%)
Note: 1) The indications with "¥" after the name of the indications represent the indications approved by both China and the United States, and the indications with "$" represent the indications approved only in the United States; 2) "Other indications" include stomach Intestinal malignant tumor, chest malignant tumor, gastric cancer, intestinal cancer, inguinal malignant tumor, biliary tract cancer, abdominal pain, appendix malignant tumor, mesothelioma, intestinal obstruction, diabetes, ascites, small bowel cancer, intracranial space-occupying lesions, colitis , Pelvic malignant tumor, pleural effusion, sacral malignant tumor, gynecological examination, bone cancer, jaundice, enteritis, lung infection, connective and soft tissue malignant tumors, prostate cancer, scrotal malignant tumor, sacral malignant tumor, duodenum Polyps, gastrointestinal bleeding, thyroid cancer
Figure 14 The proportion of prescription amounts of rituximab antigen research and biosimilar drugs in each indication in Shanghai sample hospitals (%)
Note: 1) The indications with "¥" after the name of the indications represent indications approved in both China and the United States, and the indications with "$" represent indications approved only in the United States; 2) "Other lymphomas" are included It is unknown whether it is a type of non-Hodgkin's lymphoma, such as liver lymphoma, splenic malignant lymphoma, other non-follicular lymphoma, lymphangioma, malignant lymphoma, etc.
In general, biosimilar drugs are slowly replacing the original research market at a steady pace, and more "tactics" of following the original research are adopted in hospital admissions and prescriptions.