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Rapid expansion of GLP-1 therapies disrupts pharma landscape GLP-1 (glucagon-like peptide-1) receptor agonists, once niche products, have captured global attention due to their effectiveness in managing diabetes and supporting weight loss

Because of this complexity, BPCIA requires biosimilar applicants to conduct clinical trials demonstrating biosimilarity, unlike ANDA applicants who only need bioequivalence studies

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7 Notably, the PIONEER-6 (A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes) 1 and AWARD-11 (Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus Dulaglutide 1.5 mg in Metformin-Treated Patients With Type 2 Diabetes) 19 studies did not show a worsening of DR or other retinal complications

Bao L, Yin J, Gao W, Wang Q, Yao W, Gao X (2018) A long-acting FGF21 alleviates hepatic steatosis and inflammation in a mouse model of non-alcoholic steatohepatitis partly through an FGF21-adiponectin-IL17A pathway

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