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The FDA has generally recommended switching studies to show evidence of interchangeability of a biosimilar. Regulatory reform is needed so patients can more easily access biosimilars and draw ...
Dorzolamide/timolol, sold under the brand name Cosopt among others, is a medication used to treat high pressure inside the eye including glaucoma. [3] [5] [6] It is a combination of dorzolamide hydrochloride and timolol maleate. [3] It may be used when a beta blocker, like timolol, is not sufficient alone. [7] It is used as an eye drop. [3]
The anti-TNF-α monoclonal antibody infliximab is a major biological therapy for inflammatory bowel disease Biological therapy, the use of medications called biopharmaceuticals or biologics that are tailored to specifically target an immune or genetic mediator of disease, plays a major role in the treatment of inflammatory bowel disease. [ 1 ]
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 .
Regeneron has filed lawsuits against companies such as Amgen and Biocon, which are seeking to bring Eylea biosimilars to the U.S. market.Regeneron recorded U.S. sales of $5.72 billion from its ...
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 ]