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Infliximab, a chimeric monoclonal antibody, sold under the brand name Remicade among others, is a medication used to treat a number of autoimmune diseases. This includes Crohn's disease , ulcerative colitis , rheumatoid arthritis , ankylosing spondylitis , psoriasis , psoriatic arthritis , and Behçet's disease . [ 23 ]
Instead there are biosimilars. Biosimilars are defined by the FDA as, "a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product." [28] Currently, the only two biologic treatments for IBD that have approved biosimilars are adalimumab and infliximab. [11]
The first biosimilar of a monoclonal antibody to be approved worldwide was a biosimilar of infliximab in the EU in 2013. [9] On March 6, 2015, the FDA approved the United States' first biosimilar product, the biosimilar of filgrastim called filgrastim-sndz (trade name Zarxio) by Sandoz .
The global market for biosimilars, or generic versions of biologic medical products, is expected to soar to $24 billion by 2019, according to a recent report from Frost & Sullivan -- not bad for a ...
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Sandoz is relying on biosimilars to boost profitability. The Swiss company has said that its adjusted core profit margin would likely be 18-19% this year, down from 21.3% in 2022, weighed down by ...
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