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The anti-TNF-α monoclonal antibody infliximab is a major biological therapy for inflammatory bowel diseaseBiological 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]
Infliximab was approved for medical use in the United States in 1998, [23] and in the European Union in August 1999. [19] Infliximab biosimilars have been approved in the EU (2013), in Japan (2014), and in the United States (2016, 2017, 2019). [1] [4] [2] It is on the World Health Organization's List of Essential Medicines. [25]
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 ...
[4] [9] Adverse effects may be class-dependent, and so switching to a biologic of another class may ameliorate those effects. [ 7 ] Potential serious adverse effects include allergic reactions , liver damage, cancer, and serious infections including tuberculosis , pneumonia , staph infection , and fungal infection .
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.
When switching antidepressants, your healthcare provider may recommend switching directly, cross-tapering or tapering down your dosage before you start using your new medication.
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