LG Chem to get approval for sale of biosimilar Japanese etanercept ----------------------------------------- Thanks for watching video. Don't forget subscribe this channel: https://goo.gl/bBBK38
In this short video, PAREXEL expert Dr. Cecil Nick, Vice President-Biotechnology, compares current FDA & EMA requirements for biosimilars.
With biosimilar biological products moving from the lab to the marketplace, key policy and regulatory questions are being actively debated, with important implications for industry, patients, and the health care system. This discussion provides background on current policy and regulatory issues surrounding biosimilars. The panel discussion includes the following experts: Leah Christl, associate director for therapeutic biologics, The Food and Drug Administration (FDA) Barbara Finck, chief medical officer, Coherus Biosciences Brian Lehman, manager of pharmacy benefits and policy, Ohio Public Employees Retirement System (OPERS) Leigh Purvis, director of health services research, AARP Angus Worthing, rheumatologist and member of ACR Government Affairs Committee, American College of Rheumatology Sarah Dash of the Alliance for Health Reform moderates.
Lupin has formed a joint venture with Japanese pharma company Yoshindo to develop a robust pipeline of bio-similars for the market. This further strengthens its presence in the Japanese market. Priya Sheth shares a detailed report on the same. This video is originally sourced from Bloomberg TV India, you can watch it here: http://www.btvin.com/videos/watch/6811/Lupin-Inks-JV-With-Japan%27s-Yoshindo-
In this video, Stephane Houel, Waters Corporation, describes a method for in-depth characterization of O-linked glycosylation of Etanercept and the comparison of O-glycosylation heterogeneity between the innovator Etanercept and a biosimilar.
Klaus Martin, Head Biopharmaceuticals in Polpharma Biologics talks about biosimilars market in Poland. He specifies it and underlines challenges that it still need to overcome. Klaus Martin, starszy dyrektor ds. produktów biotechnologicznych i rozwoju biznesu Polpharma Biologics opowiada o rynku produktów biopodobnych w Polsce. Charakteryzuje go, a także wymienia wyzwania, jakie wciąż stoją przed jego rozwojem. Więcej ciekawych publikacji odnajdziesz na portalu biotechnologia.pl ©Biotechnologia.pl/ Cebiotech.com
BIOSIMILARS- Regulatory Framework and Pipeline Analysis provides market dynamics, key players, therapy area, development phase, legal strategies, action mechanism, late stage products, competition prediction, indications, healthcare expenditure, trends, growth drivers, barriers, scope and a lot more.
Get Full Details On: http://www.researchbeam.com/global-biologics-and-biosimilars-industry-2015-deep-research-report-market Global Biologics And Biosimilars Industry Size, Share, Market Trends, Growth, Analysis, Capacity, Production, Cost, Price, Profit, Production Value, Report 2015 Report Overview Research Beam adds a report titled “Global Biologics And Biosimilars Industry 2015 Deep Market Research Report” that provides detailed information of the Global Biologics And Biosimilars Industry. The report is an excellent piece of study for investors who are looking towards the market. For overview analysis, the report introduces Biologics And Biosimilars basic information including definition, classification, application, industry chain structure, industry overview, policy analysis, and news analysis, etc.For international and China market analysis, the report analyzes Biologics And Biosimilars markets in China and other countries or regions (such as US, Europe, Japan, etc.) by presenting research on global products of different types and applications, developments and trends of market, technology, competitive landscape, and leading suppliers’ and countries’ 2009-2014 capacity, production, cost, price, profit, production value, and gross margin. For leading suppliers, related information is listed as products, customers, application, capacity, market position, and company contact information, etc. 2015-2020 forecast on capacity, production, cost, price, profit, production value, and gross margin for these markets are also included. For technical data and manufacturing plants analysis, the report analyzes Biologics And Biosimilars leading suppliers on capacity, commercial production date, manufacturing plants distribution, R&D status, technology sources, and raw materials sources.
Infliximab (trade names Remicade among others) is a chimeric monoclonal antibody biologic drug that works against tumor necrosis factor alpha (TNF-α) and is used to treat autoimmune diseases. Infliximab was approved by the U.S. Food and Drug Administration (FDA) for the treatment of Crohn's disease, ulcerative colitis, psoriasis, psoriatic arthritis, ankylosing spondylitis, and rheumatoid arthritis. It is used off-label outside its FDA approval for Behçet's disease and other conditions. Infliximab is administered by intravenous infusion, typically at six- to eight-week intervals. It cannot be given by mouth because the digestive system would destroy the drug. Infliximab works by binding to TNF-α. TNF-α is a chemical messenger (cytokine) and a key part of the autoimmune reaction. In rheumatoid arthritis, infliximab seems to work by preventing TNF-α from binding to its receptor in the cell. Infliximab is an artificial antibody. It was originally developed in mice as a mouse antibody. Because humans have immune reactions to mouse proteins, the mouse common domains were replaced with similar human antibody domains. They are monoclonal antibodies and have identical structures and affinities to the target. Because they are a combination of mouse and human antibody amino acid sequences, they are called a "chimeric monoclonal antibody". In the United States, Remicade/infliximab can cost $19,000 to $22,000 a year per patient, according to Centocor in 2007. Infliximab biosimilars have been approved in the EU (2013), Japan (2014), and USA (2016).
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