The first domestic bevacizumab biological similar medicine is coming! Roche Aventine 2 billion status not guaranteed?

Roche Aventine welcomes the challenger! On December 9, the State Food and Drug Administration issued an announcement to approve the application for listing and registration of bevacizumab injection (trade name: andar) developed by Qilu pharmaceutical Amdal is the first biologically similar bevacizumab approved in China, which is mainly used for the treatment of patients with advanced, metastatic or recurrent non-small cell lung cancer and metastatic colorectal cancer According to the data, the bevacizumab injection approved by Qilu pharmaceutical is the first domestic product developed and applied for production by the way of biological similar drugs with the original bevacizumab as the reference drug It has obtained the special support of national major new drug creation The State Food and Drug Administration approved the product to be listed in accordance with the priority review and approval procedure Qilu leads the way More than 10 enterprises queue up for bevacizul monoantigen research drug (avidin), developed by gene tech, a member of Roche Group, is a humanized anti VEGF monoclonal antibody, which can inhibit tumor angiogenesis, cut off the blood supply of tumor area, inhibit tumor growth and metastasis, and thus produce anti-tumor effect Bevacizumab, as one of the important anti-tumor angiogenesis drugs, has been used in the treatment of many kinds of malignant tumors Avidin was listed in the United States in 2004, with a global sales revenue of $7 billion in 2018, occupying the seventh place in the list of global best-selling drugs in 2018 Avidin was approved in China in 2010, and its sales in China exceeded 2 billion yuan in 2018 The patent for antibody sequence of the original research drug expires in the United States, Europe and China in 2019, 2018 and 2018 respectively As of May 2019, two Chinese enterprises have submitted the application for listing bevacizumab bio similar drugs In addition to Qilu pharmaceutical ql1101, the other is Xinda bio's ibi305 In addition, bevacizumab biological analogues from 10 enterprises such as baiaotai have progressed to the third stage of clinical practice The following is a list of bevacizumab biological analogues entering clinical phase III and submitting NDA applications in China: bevacizumab is currently approved for two indications in China - metastatic colorectal cancer and non-small cell lung cancer Bevacizumab is widely used in colorectal cancer, non-small cell lung cancer and other high-risk cancer species According to the report of frost Sullivan, the number of new cases of NCN will reach 1 million 42 thousand in 2030 The number of patients with metastatic colorectal cancer will reach 170 thousand in the same period The aging of the population will lead to a gradual increase in the incidence rate The huge cancer patient pool will greatly promote the development of bevacizumab market (photo source: baiaotai prospectus) a number of biological analogues will be listed, and Roche Aventine will face the impact With the increase of the number of bevacizumab bio analogues on the market in China, the market scale of bevacizumab bio analogues in China will grow steadily According to frost Sullivan report, with the first bevacizumab bio analogues on the market, the market will increase to 6.4 billion yuan in 2023, and reach 9.9 billion yuan in 2030 In 2017, bevacizumab was included in the category B scope of the national medical insurance catalog Before entering the medical insurance, the median winning price of the drug was 5253 yuan (100mg / bottle) After this round of medical insurance negotiation, the price was reduced to 1998 yuan (100mg / bottle), and further reduced to 1934 yuan (100mg / bottle) in 2018, and the reimbursement rate was as high as 70% - 90% The payment pressure of patients was relieved Although the price of Roche's Aventine has dropped significantly, its sales volume has increased significantly since then In the second quarter of 2018, the sales volume increased by 250% year on year Driven by the sales volume, the sales volume also increased by 50% It is regarded as a successful case of entering the "price for volume" medical insurance With the coming of biological analogues, the payment pressure of bevacizumab for cancer patients in China will be further reduced According to insight database, the latest bidding price of bevacizumab single antigen research is 1934.26 yuan / 4ml: 100mg, which is expected to be between 1000-1200 in Qilu There is no doubt that this will also impact the market position of Roche Aventine in China Roche's drug is also under siege Up to now, FDA has approved two bevacizumab biological analogues, mvasi and zirabev of Amgen / Erjian, respectively There are more than 20 manufacturers of bevacizumab biological analogues in the domestic market Penicillin is the reprinted content of yaozhi.com, and the copyright belongs to the original author The purpose of reprinting is to transmit more information, which does not represent the view of this platform If the content of the work, copyright and other issues are involved, please contact our website message, we will delete the content in the first time.