Sword refers to Luo's meiluohua! Amgen / Erjian biopharmaceutical abp798 (rituximab) has applied for listing in the United States!

December 21, 2019 / BIOON / - Amgen and partner Allergan recently announced that they have submitted the BLA of abp798 (rituximab) to the U.S Food and Drug Administration (FDA), which is the product of rituxan Biosimilars At present, the two sides are cooperating in the development of four tumor student generic drugs, two of which have been approved by FDA Abp798 is a monoclonal antibody with the same amino acid sequence as rituxan Rituxan is a therapeutic monoclonal antibody targeting CD20, which has been approved in many countries around the world It can be used to treat: (1) a variety of oncological indications, including non Hodgkin's lymphoma (NHL), chronic lymphoblastic leukemia (CLL); and (2) a variety of autoimmune disease indications, including rheumatoid arthritis (RA), granulomatous polyangitis GPA, microscopic polyangitis (MPA), pemphigus vulgaris (PV) The BLA submission is based on data including analysis, pharmacokinetics and clinical data, as well as pharmacological and toxicological data generated in two clinical studies The results of these studies confirm that there is no clinically significant difference between abp798 and rituxan David M Reese, MD, executive vice president of Amgen research and development, said: "the abp798 application in the United States marks an important milestone for the company, because it embodies our commitment to provide high-quality bio generic drugs, provide more life-changing bio therapy options, and help the sustainability of the medical system We look forward to working with FDA to bring abp798 to market " Currently, there are 10 biosimilars in the pipeline, including 4 approved in the United States and 3 approved in the European Union Rituximab, Herceptin and Avastin are three of Roche's top biopharmaceuticals According to the data released by Gen in April this year, the global sales of the three drugs in 2018 were CHF 6.752 billion, CHF 6.982 billion and CHF 6.849 billion respectively, and the total sales in the U.S market was USD 10.14 billion According to the FDA database of biosimilars, up to now, 26 biosimilars have been approved by the FDA, including 9 for Roche's three trump brand biosimilars: avidin (2), Herceptin (5), and rituximab (2) In July this year, Amgen and Erjian announced the launch of mvasi (bevacizumab) and kanjinti (trastuzumab) in the U.S market, which are the first avidin biosimilars and the first Herceptin biosimilars in the U.S market In November, TIWA and its partner celltrion launched truxima (rituximab), the first bio generic drug of rituximab, in the United States This means that in the U.S market, Roche's three trump biological agents have been completely occupied Original source: Amgen and Allergan submit biology license application for ABP 798, biosimilar candidate to rituxan ® (rituximab), to U.S Food and Drug Administration