echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Latest Medical News > 450 million! The first domestic bio similar drug was approved for market

    450 million! The first domestic bio similar drug was approved for market

    • Last Update: 2019-02-27
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    On February 22, the State Drug Administration approved the listing registration application of rituximab injection (trade name: hanlikang) developed by Shanghai Fuhong Hanlin biopharmaceutical Co., Ltd It is the first biologically similar drug approved in China, mainly used in the treatment of non Hodgkin's lymphoma According to the notice of Fosun Group, as of January 2019, Fosun has invested about 453.65 million yuan in R & D of rituximab injection (including indications for non Hodgkin lymphoma and rheumatoid arthritis) Rituximab is jointly developed by Baijian and Roche (including gene Tech in the United States and Chinese and foreign pharmaceutical in Japan) It is the first monoclonal antibody approved by FDA for cancer treatment It was approved by the U.S Food and Drug Administration (FDA) on November 26, 1997, the European Drug Administration (EMA) on June 2, 1998, the Japanese pharmaceutical and medical device comprehensive agency (PMDA) on June 20, 2001, and approved by the China food and Drug Administration (CFDA) on April 21, 2008 It was also approved by Baijian and Roche in the United States, Europe, Japan and China For sale under the names of rituxan and mabthera According to the sales database of smart drugs, the sales of this drug has been rising slightly from 2011 to 2017, with an average sales volume of 45.8 billion yuan and a sales volume of 52.7 billion yuan in 2017 Rituximab is a 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 cytotoxicity (CDC) and antibody dependent cytotoxicity (ADCC) The approved indications of the drug are non Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatous vasculitis and microangitis At present, rituximab injection listed in China (excluding Hong Kong, Macao and Taiwan, the same below) is only used by Shanghai Roche Pharmaceutical Co., Ltd (for non Hodgkin lymphoma indications) According to the latest data of iqviachpa, in 2017, the sales volume of rituximab injection in China was about 1.73 billion yuan Biological similar drugs refer to the therapeutic biological products which are similar to the approved reference drugs in terms of quality, safety and effectiveness The launch of bio similar drugs will help to improve the accessibility and reduce the price of bio drugs, which can better meet the public demand for bio therapy products In order to promote the healthy and orderly development of China's biopharmaceutical industry, the State Food and Drug Administration organized the drug evaluation center and other technical departments in a timely manner On the basis of the World Health Organization and relevant guiding principles at home and abroad, and the successful research and development cases of international biopharmaceuticals, combined with the actual situation and specific national conditions of China's biopharmaceutical research and development, in February 2015, it formulated and issued the research and development of biopharmaceuticals Development and evaluation technical guidelines (Trial) At present, China has become the country with the largest number of biological similar drugs in research, and nearly 200 clinical trials of biological similar drugs have been approved successively Some products have completed phase III clinical trials and submitted applications for market registration This time, rituximab injection declared by Fuhong Hanlin company is the first product in China that is developed and declared to be produced by using rituximab as reference drug according to the biological similar drug route, and has obtained the major special support of national major new drug creation technology Through comprehensive quality similarity study, non clinical similarity study and clinical comparison study, the applicant obtained the data support of safety and effectiveness of the product and submitted the application for listing registration In order to better meet the clinical needs, the State Food and drug administration, in accordance with the requirements of the opinions on deepening the reform of the review and approval system and encouraging the innovation of drugs and medical devices (Ting Zi [2017] No 42) issued by the central office and the state office, includes this product in the priority review and approval process, and simultaneously starts the production while the technical review The on-site inspection and inspection work has accelerated the listing speed of the product On February 22, the State Food and Drug Administration officially approved the production and listing of this product Lymphoma is divided into Hodgkin's lymphoma and non Hodgkin's lymphoma according to pathology Non Hodgkin's lymphoma (NHL) is a kind of malignant tumor originated from the lymphatic system, which is characterized by uncontrolled proliferation of abnormal lymphoma cells in lymphoid organs (lymph nodes, spleen, etc.) or non lymphoid organs, resulting in enlargement of lymph nodes, destruction of organ structure, compression and obstruction of adjacent organs, and accompanied by systemic symptoms The disease can occur in any age group, is a very complex group of diseases The proportion of non-Hodgkin's lymphoma is much higher than that of Hodgkin's lymphoma in China The approved rituximab injection is mainly used for the treatment of non-Hodgkin's lymphoma, including three subgroups: (1) treatment of recurrent or resistant central follicular lymphoma; (2) previously untreated CD20 positive stage III-IV follicular non-Hodgkin's lymphoma; (3) cd20bj diffuse large B cell non-Hodgkin's lymphoma In recent years, the State Food and drug administration has earnestly implemented the requirements of the State Council on "accelerating the registration and approval of new anti-cancer drugs at home and abroad to meet the urgent needs of patients", with the goal of protecting and promoting public health, and focused on solving the problem of public access to drugs In 2018 alone, 18 new anti-cancer drugs were approved for listing Next, the State Food and Drug Administration will further deepen the reform of drug review and approval system, continue to increase efforts, continue to accelerate the implementation of a series of policies and measures for the listing of overseas new drugs, and accelerate the registration and approval of domestic new anti-cancer drugs to better meet the clinical needs of patients.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.