With the expiration of the original biopharmaceutical patents and the continuous development of biotechnology, biosimilar drugs developed on the basis of the original biopharmaceuticals have entered the fast lane of development. The latest announcement of Fosun Pharma, a listed company, said that its holding subsidiary, Fuhong Hanlin, a biosimilar drug for the treatment of non-Hodgkin's lymphoma, was recently accepted by the State Food and Drug Administration for drug registration review. In the industry's view, the drug is expected to sprint the first biosimilar drug listed in China after the release of the 2015 "Technical Guidelines for the Development and Evaluation of Biosimilar Drugs (Trial)". Under the policy dividend of the country to encourage the development of biosimilar drugs, Chinese and foreign pharmaceutical companies have accelerated their market layout in China.
Domestic blanks are expected to be broken
According to the above guiding principles, biosimilar drugs refer to therapeutic biological products that are similar in quality, safety and effectiveness to approved reference drugs (usually original products). Because biosimilars can better meet the public's demand for biotherapeutic products, help improve the accessibility of biopharmaceuticals and lower prices, many countries attach great importance to the development and management of biosimilars, and there are more than 20 globally. Countries or organizations have developed guidelines for biosimilar drugs.
However, since biological structure and technology production are far more complicated than chemical generic drugs, biosimilar drugs are in the initial stage on a global scale, especially for antibody-like organisms. No more than 10 approved by European and American countries are still blank in China.
Recently, Fosun Pharmaceutical's subsidiary Fuhong Hanlin Biotech announced that the company's rituximab injection (a biosimilar drug, recombinant human mouse chimeric anti-CD20 monoclonal antibody injection) won the national food The State Council of the People's Republic of China accepts the drug registration review. This drug is a macromolecular biosimilar drug independently developed by Fuhong Hanlin. It is mainly used for the treatment of non-Hodgkin's lymphoma and rheumatoid arthritis.
According to public data, the incidence of malignant lymphoma was about 6.68/100,000 between 2003 and 2013, ranking the eighth in all malignant tumors. In terms of disease classification, lymphomas are usually divided into two broad categories: Hodgkin's lymphoma (10% of all lymphomas) and non-Hodgkin's lymphoma (90% of all lymphomas).
As of October 30, 2017, rituximab injections marketed in China (excluding Hong Kong, Macao and Taiwan) are only Meiluohua of Shanghai Roche Pharmaceutical Co., Ltd. According to the IMS statistics of the consulting agency, the sales 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 3400 yuan / 0.1mg, 16000 yuan / 0.5mg or more) so many patients can not afford, there are many patients because the treatment is very heavy on the back economic burden.
It is worth noting that once the domestic rituximab is on the market, high-quality and low-cost biosimilar drugs will quickly cover patients with actual drug needs but cannot afford the drug price. Qin Shuzhen, chairman of the China Society of Clinical Oncology Foundation, said that as biosimilars continue to be marketed in China, they provide better choices for clinicians and allow more patients to receive treatment.
Chinese and foreign pharmaceutical companies seize the market for biosimilar drugs
According to statistics, there are 7 biopharmaceuticals among the top 10 global sales in 2016, 6 of which are monoclonal antibodies, and the sales of the king of the monoclonal antibody, Xia Mei Le (Adalimumab), reached 16 billion US dollars. The concern of Chinese and foreign pharmaceutical companies.
Compared with 2013-2015, it is the concentrated expiration time of non-monoclonal biopharmaceutical patents. 2016-2020 will usher in the peak of patent expiration of monoclonal antibody, and the global market for biosimilar drugs is coming soon. It is worth noting that in addition to domestic pharmaceutical companies such as Fuhong Hanlin, CITIC Guojian, and Cinda Bio, Amgen, Novartis, Pfizer and other multinational pharmaceutical giants are also important players in the biosimilar market.
From the research pipelines of major companies, biosimilar drug research and development focused on adalimumab, infliximab, rituximab, bevacizumab, trastuzumab and other patents have expired or are about to expire The large variety of monoclonal antibodies. The market expects that the global biosimilar drug market will reach $35 billion in 2020.
Compared with chemical generics, the technical threshold and investment threshold for biosimilar drugs are much higher. Fosun Pharma announced that as of September 2017, R&D expenses for rituximab have been invested in about 290 million yuan. Since its inception in 2010, Fuhong Hanlin has invested approximately 864 million yuan in the development of monoclonal antibody products. In addition to rituximab (HLX01 project), the company's HLX02 project (Roche Herceptin's biosimilar drugs) has been Phase III clinical trials of breast cancer were conducted in the EU and Poland.
In addition to doing their own work, domestic pharmaceutical companies have chosen to join forces with foreign giants. Recently, Xiansheng Pharmaceutical and Amgen announced that it has launched a strategic alliance of biosimilar drugs to introduce biosimilar drugs of several monoclonal antibodies to China for joint research and development and commercialization. This is a biosimilar drug between Chinese and American pharmaceutical companies. For the first time, the field started a large-scale cooperation.
Cooperative drugs from both sides include adalimumab for the treatment of rheumatoid diseases and bevacizumab for the treatment of tumors. These biosimilars are the first biosimilars in their respective categories approved by the FDA. Zhang Wenjie, general manager of Amgen China, said that this cooperation combines the long-term expertise and advantages of Amgen in biopharmaceutical R&D and production, as well as the local development registration experience and strong strength of Xiansheng Pharmaceutical in rheumatoid immunity and oncology diseases. Marketing ability.
Drug trial reform continues to stimulate market innovation
The vigorous development of biosimilar drugs in China has benefited from the continuous advancement of drug trial reform in China.
In recent years, the State Food and Drug Administration has successively implemented pilot programs for drug listing permit holders, reform of chemical drug registration classification, consistency evaluation of generic drug quality and efficacy, priority review and approval, and self-examination of clinical trial data. In the pharmaceutical industry, there has been a wave of reforms.
Biosimilar drugs are the focus of reform. In 2015, the “Technical Guidelines for the Development and Evaluation of Biosimilar Drugs (Trial)†was issued, and the registration requirements for biosimilar drugs, registration categories, and application materials were regulated. In 2016, the “Regulations on the Administration of Drug Registration (Revised Draft)†proposed that “the examination and approval of drug listing applications should focus on: the similarity and efficacy of biosimilar drugs and original drug researchâ€.
Domestic health insurance has also opened the door for biosimilar drugs. In April 2017, the Ministry of Human Resources and Social Security issued a notice to determine the scope of negotiations for the 2017 National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug List. Of the 44 drugs, 7 were related to monoclonal antibodies, indicating that the health care sector fully recognized the clinical value of monoclonal antibodies.
Fosun Pharma said that it has established three pharmaceutical R&D laboratories in Silicon Valley, USA, and has established a global R&D network that seamlessly cooperates with Shanghai and Chongqing. Based on this research and development network, Fosun currently has 11 global clinical approvals for tumor and autoimmune diseases. Oncology drug leader Hengrui Medicine is also continuing to increase its R&D investment. The financial report shows that in the first half of 2017, the company invested a total of 780 million yuan in research and development, a year-on-year increase of 60%, basically forming a benign development trend of applying innovative drugs every year.
Song Ruilin, executive director of the China Pharmaceutical Innovation Promotion Association, pointed out that the new policy of the regulatory authorities has stimulated the vitality of the entire pharmaceutical industry, and at the same time promoted the international cooperation of local enterprises and the accelerated pace of international companies entering the Chinese market. By promoting the level of supervision in the cooperation with the international level, the overall level of China's biomedical industry will be improved. (Economic Information Daily)
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