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    Home > Active Ingredient News > Drugs Articles > China's first bio similar drug was approved to be on the market, and its original research was shortlisted as the top 10 best selling drug in the world for 10 consecutive years

    China's first bio similar drug was approved to be on the market, and its original research was shortlisted as the top 10 best selling drug in the world for 10 consecutive years

    • Last Update: 2019-02-26
    • Source: Internet
    • Author: User
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    On February 25, the National Drug Administration (nmpa) released the news that rituximab injection (trade name: hanlikang) of haifuhong Hanlin biopharmaceutical Co., Ltd was approved for listing As this is the first biological similar drug approved in China, it has a milestone significance and quickly triggered hot debate in the pharmaceutical industry Figure 1 is from the nmpa website We can't help but ask why the first biologically similar drug in China is rituximab? In fact, if we have a deeper understanding of rituximab antigen research, we will find that the reason is that rituximab antigen research is too excellent! Rituximab was originally developed by Genentech company (Roche) It is the first monoclonal antibody approved by FDA for the treatment of cancer It is mainly used for the treatment of non Hodgkin's lymphoma In recent years, the sales volume of rituximab has been in the top 10 of the global drugs, showing the king's demeanor Let's take a look at the top 10 list of global drug sales in 2018 As can be seen from Figure 2, the sales volume of rituxan reached US $3.483 billion in 2018, ranking fifth in the global drug sales list Of course, this is not the best result achieved by rituxan, which once ranked the top three in global drug sales in 2017, reaching US $7.935 billion! Figure 2 global drug sales in 2018 TOP10 from Figure 2, we can also see that there are only eliquis and Revlimid listed drugs in the top 10 drugs, and biological drugs account for 80%, especially McAbs, accounting for 70% Therefore, the imitation of these excellent McAbs is also the focus of the work of major imitation enterprises in the world In addition, we can also see that Roche holds 3 seats in the top 10 list, which is the pharmaceutical enterprise with the largest number of drugs in the list, and all of them are McAbs Thus, the development of biological drugs including McAbs has been rapid in recent years, which is the place for many pharmaceutical enterprises to compete Figure 3 the top 10 list of global drug sales in 2014-2018 Figure 3 is the top 10 list of global drug sales in 2014-2018 From the figure, we can see that rituxan has been in the top 10 list for many years and ranked in the top three in 2015 and 2017 In fact, we can further find that in the 10 years from 2009 to 2018, rituxan has been in the top 10 list of global drug sales, bringing a lot of benefits to Roche and bringing benefits to countless patients, which can be called the "golden decade"! It is reasonable for many pharmaceutical companies to imitate such an excellent McAb It is reported that in China alone, more than 10 pharmaceutical companies have carried out imitation research on it, including Fuhong Hanlin, Sansheng Guojian, Haizheng pharmaceutical, Zhengda Tianqing, Xinda biology, Hualan biology, Lizhu mAb, etc Fuhong Hanlin is one of the first enterprises to carry out rituximab biological analogues It is reported that Fuhong Hanlin has adopted highly expressed cell lines, increased the average production of 1G / L cell lines to 3G / L, and adopted advanced one-time production technology The cell culture medium is also independently developed by the company, which has been considered from the aspects of factory building and production capacity, compared with imported original research drugs, It will have a great advantage in price Because of the high complexity of biological drugs such as monoclonal antibodies, it is difficult to develop biological analogues However, thanks to the rapid development of biotechnology in recent years, the development of biopharmaceuticals in China is also changing with each passing day Although it has been four years since 2015 when China officially issued the regulatory policy document of biological similar drugs - "technical guidelines for research and development and evaluation of biological similar drugs (Trial)" - until now, the first biological similar drug rituxan has been approved and successfully listed, rituxan has obviously opened up a good start for biological similar drugs in China and provided valuable information Our experience is a milestone of "from nothing to have" and "from zero to one" Reference materials: 1 Http:// 2 Technical guidelines for R & D and evaluation of similar biological drugs (Trial).
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