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Regulatory approval of new biosimilars requires an extensive comparability exercise against established and marketed reference products as it must include quality and clinical studies to demonstrate a high percentage of similarity in both terms of structure and function

Which clinical criteria do insurers commonly require for GLP-1 approval

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kg/m2) from baseline to 3 months after either stopping dulaglutide without replacement or switching to other glucose-lowering medications due to a shortage of dulaglutide

For gastroenterologists and colorectal specialists, anorectal manometry (ARM) is becoming a crucial tool to evaluate and manage these symptoms with greater precision