Domestic monoclonal antibody is expected to be listed in the second half of the year
At present, the fastest progress in the research and development of biosimilar drugs in China which has already been during the application for production is made by Henlius for its rituximab (anti-cd20 monoclonal antibody) which is expected to be approved for production within this year. Camrelizumab(PD-1 monoclonal antibody) of Hengrui Pharma and sintilimab(PD-1 monoclonal antibody) of Cinda Biology have been included in the public list of priority drug registration procedures issued by assessing center of China Food and Drug Administration and are expected to be approved for listing in the near future.
It is reported that there is still no biosimilars approved for market in China, but with the reform of related pharmaceutical policies in recent years, the market environment for biosimilars will be greatly improved. There is a great chance for the development of biosimilar monoclonal antibodies. The main reasons are as follows.
As of 2017, 72 therapeutic antibodies have been approved by FDA, while only 10 domestic monoclonal antibodies and 13 imported monoclonal antibodies have been approved for market in China, so the number of monoclonal antibodies products still has a long way to go. After the policy reform of CFDA, imported anti-cancer drugs will be able to enter the Chinese market without tariff, and foreign companies can be urged to submit clinical applications in China as soon as possible.
Monoclonal antibody is highly recognized clinically, but its high price limits the promotion of monoclonal antibody drugs.
The domestic monoclonal antibody market is far less competitive than the developed countries in Europe and America in aspects of sales scale, product quantity and type, the reason for which is the high price, above all. Before 2009, monoclonal antibody drugs were all paid by patients at their own expense. After 2009, only 5 products were included in the medical insurance directory of some provinces successively. Most of the products were not covered by medical insurance in most regions, and the high price limited the clinical promotion of monoclonal antibody.
In July last year, 36 drugs, including six monoclonal antibodies, were cut in national drug price negotiations. Sales of cut-price drugs fell briefly after the fourth quarter of last year, but quantity of sales has risen sharply. Thus it can be seen that the price of products is the main limiting factor of volume.
However, the excellent efficacy of monoclonal antibody drugs has been widely recognized by foreign clinical tests for many years, and domestic experts have repeatedly proposed that monoclonal antibody drugs should be included in the scope of medical insurance reimbursement. The Ministry of Human Resources and Social Security accepted the proposal and published the new version of the directory of medical insurance on February 24th , 2017. For the first time, two monoclonal antibodies, namely recombinant human type II tumor necrosis factor receptor-antibody fusion protein and baliximab, were included in the directory.
Generic drugs have obvious substitution effect on the existing market of the original developed drugs.
After the consistent evaluation, there have been some high-quality and expensive generic drugs on the market. As an example, Novartis had an original developed drug "Gleevec" which was listed in China in 2002 and the patent protection expired in March 2013. However, after its generic drug was listed after the consistent evaluation, the sales amount of Gleevec decreased significantly, indicating that the generic drug would seize the market of the original developed drug or even replace the original developed drug.
Apart from PD-1 from Hengrui and Cinda , the editor is also optimistic about BeiGene, the progress of which should be similar to that of those two companies.
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