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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 is a purified, recombinant DNA-derived chimeric human-mouse IgG monoclonal antibody that consists of mouse heavy and light chain variable regions combined with human heavy and light chain constant regions. [48] It has a serum half-life of 9.5 days and can be detected in serum 8 weeks after infusion treatment. [48]
[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 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 ...
Cetrelimab [5] mab: human: PD-1: cancer Cetuximab [32] Erbitux: mab: chimeric: Epidermal growth factor receptor (EGFR) Y: metastatic colorectal cancer and head and neck cancer: Cibisatamab [5] mab: humanized: CEACAM5: cancer Cilgavimab [29] mab: human: spike protein receptor binding domain (RBD) of SARS-CoV-2: US emergency use authorization ...
The agency approved Biocon Biologics' Yesafili as well as Samsung Bioepis and Biogen's Opuviz, while also allowing interchangeability, or the drug's substitution with biosimilars without the need ...
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