FDA approves Tivattozumai anti-biosimilar herzuma for HER2-positive breast cancer treatment
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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, South Korea's bio
pharmaceutical(http://company(http://Celltrion and partner Teva announced that the U.SFood andDrug(http://Administration (
FDA(http://) has approved the zotozocopy herzob anti-biosimilar her2 for her2-positive breast cancer treatmentthe brand-name drug for Herzuma
Herzuma, which is owned by Roche's super-heavyweightproduct
(http:// Herceptin (Hercetin, generic name: trastuzumab, qutozumab), which generated global sales of $7 billion in 2017 Herzuma complies with the FDA's strict biosimilar standards This approval is based on a review of a comprehensive packet of basic analysis (http:// similarity data, non-clinical pharmacology, immunogenicity, clinical efficacy, and security data The results of Herzuma's clinical development project sit tally show no clinical difference in purity, efficacy, and safety in the treatment of HER2 high expression breast cancer Herzuma is suitable for: (1) assisted treatment of HER2 overexpression lymph node positive or lymph node negative (ER/PR negative or has a high risk characteristic) breast cancer; Herzuma is also the second biosimilar approved in the United States by Celltrion and Teva Late last month, the two-year-old rituximab-abbs, a rituximab-abbs, was approved by the U.S FDA for the treatment of CD20-positive, B-cell non-Hodgkin's lymphoma (NHL) adult patients approval, making Truxima the first litoxia-monobiotic in the U.S market, is aimed at Rituxan, Roche's other super-heavyweight product, which is Roche's best-selling product and the world's second-best-selling oncology drug, with global sales of $8.11 billion in 2017
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