The blank market of biological similar drugs in China is expected to be broken

Source: economic reference report 2017-11-20 with the expiration of the original research bio medicine patent and the continuous development of biotechnology, the bio similar drugs developed on the basis of the original research bio medicine have entered the fast lane of development Fuhong Hanlin, a holding subsidiary of Fosun Pharmaceutical, has recently been accepted by the State Food and Drug Administration for drug registration and review, according to the latest announcement of A-share listed company In the view of the industry, the drug is expected to rush to the first biosimilar drug in China after the release of 2015 guiding principles for research and development and evaluation technology of biosimilar drugs (Trial) Under the policy dividend of encouraging the research and development of bio similar drugs, Chinese and foreign pharmaceutical companies have accelerated their market layout in China The domestic gap is expected to be broken According to the above guidelines, biological similar drugs refer to the therapeutic biological products that are similar to the approved reference drugs (usually the original research products) in terms of quality, safety and effectiveness Because bioequivalent drugs can better meet the public's demand for biological treatment products, help to improve the accessibility and reduce the price of biological drugs, many countries attach great importance to the research and development and management of bioequivalent drugs, and more than 20 countries or organizations around the world have developed relevant guidelines for bioequivalent drugs However, due to the complexity of biological structure and technology production compared with chemical generic drugs, biological analogues are in the initial stage in the world, especially antibody biological analogues There are no more than 10 approved by European and American countries, which are still blank in China Recently, Fuhong Hanlin biology, a subsidiary of Fosun Pharmaceutical holding company, announced that the rituximab injection (a biological similar drug, i.e recombinant human mouse chimeric anti-CD20 monoclonal antibody injection) developed by the company has been accepted by the drug registration review of the State Food and drug administration The drug is a macromolecular biological similar drug independently developed by Fuhong Hanlin, which is mainly suitable for the treatment of non Hodgkin's lymphoma and rheumatoid arthritis Public data showed that between 2003 and 2013, the incidence rate of malignant lymphoma was about 6.68/10 million, ranking the eighth incidence rate of all malignant tumors In terms of disease classification, lymphoma is usually divided into two categories: Hodgkin's lymphoma (10% of all lymphoma) and non Hodgkin's lymphoma (90% of all lymphoma) As of October 30, 2017, rituximab injection listed in China (excluding Hong Kong, Macao and Taiwan) was only Merox of Shanghai Roche Pharmaceutical Co., Ltd According to IMS, the sales volume of rituximab injection in China in 2016 was about 1.5 billion yuan However, the high cost of rituximab (Ping An Securities Research Report shows that the price is more than 3400 yuan / 0.1mg, 16000 yuan / 0.5mg) makes many patients unable to bear, and many families of patients have a very heavy economic burden because of the treatment It should be noted that once domestic rituximab is on the market, high-quality and cheap bio similar drugs will quickly cover patients with actual drug demand but can not afford the drug price Qin Shukui, President of the foundation of China Society of Clinical Oncology, said that with the continuous listing of bio similar drugs in China, it not only provides better choices for clinicians, but also enables more patients to receive treatment Statistics show that Chinese and foreign pharmaceutical companies have seized the market of bio similar drugs show that in 2016, 7 of the top 10 drugs in the world were bio drugs, 6 of which were monoclonal antibodies, and the sales of xiumeile (adamumumab), the king of monoclonal antibodies, reached US $16 billion, which attracted the attention of Chinese and foreign pharmaceutical companies Compared with 2013-2015, which is the concentrated expiration time of non McAb biological medicine patents, 2016-2020 will usher in the peak of McAb biological medicine patent expiration, and the global large market of biological similar drugs will come soon It is worth noting that in addition to domestic pharmaceutical enterprises such as Fuhong Hanlin, CITIC Guojian and Xinda biology, multinational pharmaceutical giants such as Amgen, Novartis and Pfizer are also important participants in similar biological medicine market From the perspective of the research pipeline of major companies, the research and development of bioequivalent drugs focus on the large varieties of monoclonal antibodies such as adamumab, infliximab, rituximab, bevacizumab, trastuzumab and other patents that have expired or are about to expire It is estimated that the global market space for bio similar drugs will reach US $35 billion in 2020 Compared with chemical generic drugs, the technical threshold and investment threshold of biological similar drugs are much higher As of September 2017, R & D cost for rituximab has been about 290 million yuan, according to Fosun Pharmaceutical announcement Since its establishment in 2010, Fuhong Hanlin has invested about 864 million yuan in the development of monoclonal antibody products In addition to rituximab (HLX01 project), the company's hlx02 project (biological similar drug of Roche Herceptin) has launched phase III clinical research on breast cancer in Poland and Ukraine In addition to their own work, there are also domestic pharmaceutical companies that choose to work with foreign giants Recently, Xiansheng pharmaceutical and Amgen announced the launch of a strategic alliance of bio similar drugs, introducing bio similar drugs of multiple monoclonal antibody varieties into China for joint R & D and commercialization This is the first time that Chinese and American pharmaceutical companies have carried out large-scale cooperation in the field of bio similar drugs The cooperative drugs include adalimumab for rheumatoid diseases and bevacizumab for tumors The two biologicals are the first biologicals of their respective categories approved by the US FDA Zhang Wenjie, general manager of Amgen China, said that the cooperation integrates Amgen's long-term expertise and advantages in the research and development and production of biological drugs, as well as the local development and registration experience and strong marketing ability of pioneer pharmaceutical in the fields of rheumatism immunity and tumor diseases The vigorous development of bio similar drugs in China has benefited from the continuous promotion of drug examination reform in China In recent years, the State Food and drug administration has successively implemented a series of major initiatives, such as the pilot of drug listing license holder system, the reform of chemical drug registration classification, the evaluation of quality and efficacy consistency of generic drugs, the priority of review and approval, and the self-examination and verification of clinical trial data, which has set off a wave of reform in the pharmaceutical industry Biological analogues are the focus of reform In 2015, the technical guidelines for research and development and evaluation of biological similar drugs (Trial) was issued, which regulated the application procedures, registration categories, application materials and other relevant registration requirements of biological similar drugs In 2016, the administrative measures for drug registration (Revised Version) proposed that "the examination and approval of drug listing applications should focus on the similarity of the quality and efficacy of biological similar drugs and original research drugs" Domestic medical insurance also opens the door for biological similar drugs In April 2017, the Ministry of human resources and social security issued a notice to determine the negotiation scope of 2017 national basic medical insurance, work injury insurance and maternity insurance drug catalog Among the 44 drugs, 7 involved McAbs, showing that the medical insurance department fully recognized the clinical value of McAbs Fosun Pharmaceutical said that at present, it has set up three pharmaceutical R & D laboratories in Silicon Valley of the United States, which are connected with domestic Shanghai and Chongqing to form a seamless global R & D network Based on this R & D network, at present, Fosun has obtained 11 global clinical approvals for 8 products in tumor and autoimmune diseases Hengrui pharmaceutical, the leading cancer medicine company, is also continuously increasing its R & D investment According to the financial report, in the first half of 2017, the company has invested 780 million yuan in R & D, a year-on-year increase of 60%, basically forming a benign development trend of applying for clinical innovative drugs every year Song Ruilin, executive chairman of China pharmaceutical innovation promotion association, pointed out that the new policies of the regulatory authorities have stimulated the vitality of the entire pharmaceutical industry, and at the same time promoted the international cooperation of local enterprises and the acceleration of the pace of international enterprises entering the Chinese market By promoting the level of supervision in cooperation with the international level, the overall level of China's biomedical industry will be improved.