Incretin-based therapy under pricing pressure: clinico-economic perspectives and role of biosimilar glucagon-like peptide-1 receptor agonists

The prevalence of obesity and type 2 diabetes mellitus continues to rise, imposing a substantial medical, social, and economic burden on healthcare systems worldwide. Glucagon-like peptide-1 receptor agonists have demonstrated robust efficacy in glycemic control, weight management, and cardiovascular risk mitigation, which has led to their widespread integration into clinical practice. However, the high cost of originator products, recurrent supply shortages, and inequitable access to therapy remain significant barriers, particularly within constrained healthcare budgets. This review analyzes current data on the clinical comparability of biosimilars of glucagon-like peptide-1 receptor agonists, regulatory requirements for their approval, and international experience with their clinical uptake. Particular attention is given to economic considerations, including the impact of price competition on treatment costs, out-of-pocket expenditures, and potential budgetary implications. Real-world evidence suggests that the financial burden may adversely affect treatment initiation, adherence, and timely achievement of therapeutic targets. Noteworthy is that the introduction of biosimilars does not automatically translate into substantial price reductions; this requires supportive regulatory and reimbursement policies, transparent pricing mechanisms, effective pharmacovigilance, and educational initiatives for both clinicians and patients. In the Russian context, the integration of biosimilars may enhance improved access to incretin-based therapy, provided that standards of quality, safety, and evidence-based evaluation are maintained. Achieving a balance between clinical effectiveness and economic sustainability is essential for ensuring long-term accessibility of glucagon-like peptide-1 receptor agonist therapy amid growing demand.

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