Sandoz's infliximab biosimilar zeslym approved by the European Commission
-
Last Update: 2020-06-11
-
Source: Internet
-
Author: User
Search more information of high quality chemicals, good prices and reliable suppliers, visit
www.echemi.com
recently, Sandoz announced that itscompany,, which produces the infliximab biosimilar drug Zessly, has been granted access to the European market through european commission approvalabout InfliximabInfliximab (business name: Remicade) is an IgG1 monoclonal antibody (including 25% rat protein and 75% human protein) for human mouse inserts (TNF-alpha) of tumor necrosis factor alpha (TNF-alpha) with a half-life of 8-9.5 days for the treatment of autoimmune diseasesIn August 1998, Infliximab receivedfrom theFDA (preliminary approval) for the treatment of Crohn's diseaseNovember 10, 1999, Infliximab was first approved by the FDA for the treatment of rheumatoid arthritisInfliximab works by combining to TNF-alphaTNF-alpha is a cytokine that is a key component of the autoimmune responseIn rheumatoid arthritis, Infliximab acts by binding soluble and membrane-binding TNF-alpha to inhibit TNF-alpha binding to its receptorscurrently, the FDA approves Infliximab for the treatment of psoriasis, Crohn's disease, strong orcuritis, psoriasis arthritis, rheumatoid arthritis, and ulcerative colitisthe same symptoms as infliximab for ZeslyZessly, including rheumatoid arthritis, adult Crohn's disease, pediatric Crohn's disease, adult ulcerative colitis, pediatric ulcerative colitis, strong ortinosis, psoriasis arthritis, and hollow psoriasisthe European Commission's approval is based on a comprehensive review of Zessly, includinganalysis of (preclinical and clinical data) that confirm that Zessly is highly similar in terms of safety, effectiveness and quality to its reference product, infliximab at the 20th American Society of Rheumatology (ACR20) in 2018, the Clinical Stage III Trial (REFLECTIONS B537-02) reached its main endpoint and showed the same efficacy as the reference sandoz
Sandoz is a global leader in the world-renowned Pharmaceutical (the pharmaceutical division of the giant Novartis) and the of biosimilar drugs In the past year, the company has approved three biosimilardrugs through the European Union The other two, The Ebrel biosimilars Erelzi and Thera biosimilarrix, both received EU approval in June last year Zesly is already the sixth biosimilar drug approved by Sandoz in the European Union Sandoz sales in 2017 were $101 billion, improving treatment services for more than 50 million patients worldwide
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.