Inventory of China's TOP10 biosimilar drugs
Last Update: 2020-06-19
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In March 2015, the National Drug Administration (nmpa) issued the technical guidelines for research, development and evaluation of biological similar drugs (Trial), which defined the biological similar drugs for the first time, put forward the basic principles for research, development and evaluation of biological similar drugs, and put forward specific requirements for pharmaceutical, non clinical and clinical research and evaluation of biological similar drugs< br / > biological analogues, also known as bio generic drugs, refer to therapeutic biological products with similar quality, safety and effectiveness to the approved reference drugsWith the expiration of the original bio medicine patent and the continuous development of biotechnology, the research and development of bio similar drugs based on the quality, safety and effectiveness of the original bio medicine will help to improve the accessibility of bio medicine and reduce the price, so as to meet the needs of the masses< br / > part < br / > 1 < br / > a blue ocean of China's bio similar drugs < br / > 1, < br / > 4 "domestic" bio similar drugs have been approved, ushering in a breakthrough < br / > 2019 is the first year of China's bio similar drugsOn February 25, nmpa approved the listing of rituximab injection (trade name: hanlikang ®) of Fuhong Hanlin, which is the first McAb independently developed by Fuhong Hanlin and the first "domestic" biological similar drug in ChinaAfter that, adamumumab injection (trade name: gelleli ®), adamumumab injection (trade name: ankinning ®) and bevacizumab injection (trade name: Ankai ®) developed by baiaotai biological, Haizheng pharmaceutical and Qilu pharmaceutical were approved for listing on November 7, December 6 and December 9, 2019This also marks China's breakthrough in the field of bio similar drugs in 2019chart 1Hannon Kang, globle,2,, China's bio similar pharmaceutical R & D pipeline ranks the world's firstFrom the number of R & D pipelines in various countries and regions, the Chinese mainland has 391 bio similar drugs, ranking first in the worldIndia (300) and the United States (262) are the top two, followed by South Korea (147), Russia (115), Europe (80), Taiwan (72), Japan (68), Switzerland (67) and the European Union (64)China has the largest number of research projects, which can be described as the "leader" in the field of bio similar drugs, which also reflects the fierce competition of domestic pharmaceutical enterprises in the research and development of bio similar drugs< br / > Figure 2The number of bio similar drugs under research in different countries and regions < br / > in addition, there are nearly 180 enterprises in China, Among them, the representative enterprises are Suzhou Kangning Jerry, Qilu pharmaceutical, Zhejiang Haizheng, Fuhong Hanlin, Zhengda Tianqing, Sansheng Guojian, Shuanglu pharmaceutical, Hualan gene, baiaotai, Anhui Anke biology, Jiahe biology, Harbin Pharmaceutical Group bioengineering, Tonghua Dongbao biology, Xiamen Tebao, Xinda biology, Shanghai Fudan Zhangjiang biology, etc< br / > Figure 3 The ranking of domestic research and development companies of biological similar drugs < br / > 3 < br / > the market scale of biological similar drugs is huge < br / > biological drugs is one of the fastest-growing sub industries in the pharmaceutical industry in recent years The global market scale is expected to rise from $2020 billion in 2016 to $326 billion in 2022, with a compound annual growth rate of 8.3% China's market size increased from 62.7 billion yuan in 2012 to 152.7 billion yuan in 2016, with a compound annual growth rate of 24.9% Frost & Sullivan expects that China's biopharmaceuticals will maintain an annual compound growth rate of 16.4% from 2016 to 2021, and reach a market scale of 326.9 billion yuan by 2021 With the rapid development of biological analogues, their proportion in biological drugs is increasing The next few years will be the golden stage of the development of bio similar drugs, with a huge potential market scale < br / > Figure 4 Sales volume of top 10 best-selling bio drugs in 2018 (global) < br / > Figure 5 Sales volume of top 10 best-selling bio drugs in 2018 (China) < br / > 4 < br / > favorable guidance of domestic policies < br / > in recent years, China has formulated and promulgated a number of policies to encourage research and development of bio similar drugs < br / > Figure 6 The development history of China's bio similar drug related policies < br / > in February 2015, CDE released the technical guidelines for research, development and evaluation of bio similar drugs (Trial), which for the first time clarified the definition of bio similar drugs, marking that there are basic principles to be followed for the evaluation and management of bio similar drugs in China, in order to further standardize the research and development of such drugs, The improvement of its safety, effectiveness and quality control level has laid a good foundation < br / > in July 2016, the registration management measures (Revised Version) further standardized the concept of biological similar drugs and tightened the approval standards of biological similar drugs < br / > in March 2017, the National Pharmacopoeia Committee issued a notice on Soliciting Opinions on "rules for naming common names of biological products", standardizing the method for naming common names of biological products, and there is no difference between the naming of biological similar drugs and the original research The management of biological similar drugs in China is gradually on the right track In the future, similar monoclonal antibody drugs must be declared with biological similar drugs, which is difficult to be approved in the way of new drug declaration, thus increasing the barriers of monoclonal antibody research and development This naming principle and regulation is the detailed rules for this policy guidance < br / > in July 2017, CDE issued the notice on Soliciting Opinions on "consideration of clinical research design and review of bevacizumab injection biological similar drugs", which is the first time to develop review points based on single variety R & D < br / > in October 2017, the general office of the CPC Central Committee and the general office of the State Council issued jointly the opinions on deepening the reform of the review and approval system and encouraging the innovation of drugs and medical devices, which once again clearly proposed to support the development of bio similar drugs < br / > in December 2017, the national development and Reform Commission issued the notice of the three year action plan for enhancing the core competitiveness of the manufacturing industry (2018-2020) The policy once again supports innovative drugs, and it is clear that the first bio similar drug is a high-end drug Encourage the expiration of patents with great market potential and high clinical value, and the development and industrialization of the first chemical generic drugs and biological similar drugs < br / > these policies provide favorable conditions for the development of bioequivalent drugs and are of great significance for the development of bioequivalent drugs in China < br / > part < br / > 2 < br / > China's top 10 research and development pipeline of biological similar drugs < br / > query data shows that there are about 391 biological similar drugs in China by December 2019, which is the country with the largest number of biological similar drugs In China, it has become a hot topic at present, and with a large number of original research drug patents about to expire, biological similar drugs have become a place of competition, attracting many pharmaceutical companies to layout < br / > the targets of biological analogues under research in China mainly include CD20, EFGR, VEGF, TNF, RANKL and HER2 It involves nearly 50 original drugs, including adalimumab, bevacizumab, trastuzumab, rituximab, enacept, infliximab, desudizumab, fegerstin, pefigerstin, rezumab, insulin glargine and omazumab < br / > the author selected 10 representative original drugs and sorted out, analyzed and summarized their research and development pipelines of biological similar drugs in China < br / > Table 1 Top 10 biological analogues in China < br / > 1, < br / > rituximab < br / > Figure 7 The structural formula of rituximab < br / > rituximab (rituximab ®) was jointly developed by Baijian and Roche (including gene Tech in the United States and Chinese and foreign pharmaceutical in Japan), and was approved by the food and Drug Administration of the United States (FDA) on November 26, 1997, It was approved by the National Drug Administration (nmpa) on April 21, 2008 The drug is a human mouse chimeric monoclonal antibody targeting at CD20 It binds to CD20 antigen expressed on the surface of B ‑ lymphocytes and kills tumor B cells through complement dependent cytotoxic effect (CDC) and antibody dependent cytotoxic effect (ADCC) The approved indications of the drug are non Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, Xanthomonas vulgaris, granulomatous vasculitis and microangitis < br / > on February 25 this year, the first domestic rituximab biological similar drug hanlikang ® was approved for marketing The drug is the first monoclonal antibody independently developed by Fuhong Hanlin for (1) recurrent or drug-resistant follicular central lymphoma; (2) previously untreated stage III-IV follicular non-Hodgkin's lymphoma; (3) treatment of CD20 positive diffuse large B-cell lymphoma (DLBCL), i.e all indications of the original rituximab in China As the first bio similar drug in China, hanlikang ® has been approved to fill the gap in the bio similar drug market in China, enhance the accessibility of high-quality bio drugs, and thus benefit more lymphoma patients < br / > in addition, there are 5 drugs in clinical phase III, 1 in clinical phase II, 2 in clinical phase I and 1 in preclinical research stage, The specific information is shown in the following table: < br / > Table 2 R & D pipeline of rituximab biological analogues < br / > 2 < br / > trastuzumab < br / > figure 8 Structural formula of trastuzumab < br / > trastuzumab (Herceptin ®) was developed by Genentech (a subsidiary of Roche) and approved by the US Food and Drug Administration (FDA) on September 25, 1998, On September 5, 2002, it was approved by the National Drug Administration (nmpa) Trastuzumab is a humanized IgG1 - κ monoclonal antibody, which binds to HER2 on tumor cells and mediates antibody dependent cytotoxicity (ADCC) The drug is used to treat breast cancer with overexpression of HER2, metastatic gastric cancer with overexpression of HER2 or adenocarcinoma at the junction of esophagus and stomach < br / > at present, there is no trastuzumab biological similar drug approved for marketing in China In the first tier, there are two drugs in the application stage of BLA, namely cmab-302 of Sansheng Guojian and hlx-02 of Shanghai Fuhong Hanlin Among them, Fuhong Hanlin's hlx-02 is the first trastuzumab bioequivalent drug to conduct head-to-head international multicenter clinical research and obtain application acceptance, and it is expected to become the second bioequivalent drug approved and listed by the company in China < br / > in addition to 2 drugs applied for by bla, there are 5 drugs in clinical phase III, 6 drugs in clinical phase I and 9 drugs in pre clinical research phase, The specific information is shown in the following table: < br / > Table 3 Research and development pipeline of trastuzumab biological analogues < br / > 3 < br / > bevacizumab < br / > Figure 9 Structural formula of bevacizumab < br / > bevacizumab (avidin ®) is a humanized monoclonal antibody IgG1 prepared by recombinant DNA technology, which can inhibit the binding of VEGF and its receptor through binding with human vascular endothelial growth factor (VEGF), Block the signal pathway of angiogenesis and inhibit the growth of tumor cells As one of the important anti-tumor angiogenesis drugs, it is used in the treatment of many kinds of malignant tumors < br / > the patent protection of bevacizumab in China expired in 2018 At present, there is only amdal ® of Qilu pharmaceutical in China, which was approved by the National Drug Administration (nmpa) for listing in December this year The drug is the first bevacizumab bio similar drug approved for marketing in China, which is in the first tier < br / > according to the query data, there are two biologically similar bevacizumab drugs at the stage of BLA listing application in China, namely SB-8 of Shenyang Sansheng pharmaceutical and ibi-305 of Xinda biological In addition, there are 12 drugs in clinical phase III and 11 drugs in clinical phase I research The specific information is shown in the table below: < br / > Table 4 Research and development pipeline of bevacizumab bioequivalent drugs < br / > 4 < br / > regizumab < br / > Figure 10 The structural formula of regizumab < br / > is jointly developed by Genentech (a subsidiary of Roche) and Novartis, Approved by the U.S Food and Drug Administration (FDA) on June 30, 2006, and China Central on December 31, 2011
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