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Author: drink more than music
The Center for Drug Evaluation of the State Food and Drug Administration recently announced the “Guidelines for the Similarity Evaluation of Biologicalsimilar Drugs and the Technical Guidelines for Indication Extrapolation” (No.
Among them, similarity evaluation requires consideration of five aspects: general evaluation, pharmaceutical similarity, non-clinical similarity, clinical similarity and overall similarity, and standardizes the development of the biomedical industry.
Regarding the extrapolation of indications, the "Guiding Principles" states: "On the basis of the overall similarity between the candidate drug and the reference drug, when a direct comparison of clinical trials can prove that the candidate drug is clinically similar to the reference drug in at least one indication, then It is possible to support the direct use of the candidate drug in other indications approved by China for the reference drug through the scientific demonstration of the research data and information related to the proposed extrapolation of the indication.
They all reflect the country’s cautious attitude.
One
Looking at the future biosimilar drugs from adalimumab
The "Guiding Principles" mentions adalimumab, which is a tumor necrosis factor (TNF) antagonist that specifically binds to TNF-α and blocks its interaction with p55 and p75 cell surface TNF receptors.
Chinese companies are also actively conducting research and development of biosimilar drugs.
The following data all come from the CPM new drug development and testing database (http://cpm.
Figure 1 Summary of indications for domestic adalimumab on the market
We can find that the four companies that have completed product listings are actively expanding indications and conducting related clinical trials; in addition, China National Pharmaceutical Group, Shenzhou Cell Engineering Co.
In terms of the market performance of adalimumab, according to the statistics of the PDB drug comprehensive database, after the entry of adalimumab into my country’s medical insurance at the end of 2019, despite the impact of the epidemic, the sales volume still increased greatly, and the total sales amount reached 59 million yuan.
Figure 2 Sales of Adalimumab over the years
Figure 3 Comparative analysis of adalimumab and monoclonal antibody sales
Analyzing the sales of adalimumab of various companies, it is found that AbbVie has performed poorly in the sample hospital market since 2012.
In Q1-Q3 of 2020, AbbVie’s sales reached 47 million yuan, accounting for 80.
Figure 4 Sales of Adalimumab in recent years
Figure 5 Market share of Adalimumab
two
summary
As biosimilars are key areas of national support, standardization and institutionalization are inevitable.
Previously, Chen Jinfu, deputy director of the National Medical Insurance Administration, also pointed out at the State Council’s policy briefing that “there are differences in the quality evaluation methods of biosimilar drugs and chemical drugs, but they also have strict quality standards.
According to data from the CPM new drug R&D testing database and the PDB drug comprehensive database, China’s biosimilar drugs are booming.
Overall, the author believes that the "Guiding Principles" and the upcoming centralized procurement of biosimilar drugs will increase the time cost of pharmaceutical companies to market their products in a short period of time.
