Biosimilars in Argentina: Market and regulatory status

Biosimilars are biological drugs that closely resemble a reference product (RP) without clinically meaningful differences in quality, efficacy, or safety. Their primary objective is to enhance access to affordable treatments, necessitating adherence to varied global regulatory guidelines. This paper analyzes Argentina’s biosimilar regulations, including the latest 2025 guidelines on comparability and the stance of medical societies, comparing them with international guidelines from Brazil, the European Union, and the United States – with a focus on definitions, comparability, interchangeability, extrapolation, pharmacovigilance, and traceability. A key finding of this study is Argentina’s lack of specific regulatory guidance on interchangeability and substitution, which contrasts with international practices. Seven Argentinian medical associations generally support biosimilar use, particularly in fields, such as autoimmune, dermatological, gastrointestinal, rheumatic, and endocrine diseases, recognizing their potential to reduce costs and enhance patient access. However, these societies advocate caution regarding interchangeability and automatic substitution due to limited supporting evidence, favoring physician-approved product changes and robust pharmacovigilance. As of April 2025, Argentina’s biosimilar market is expanding, with over 67 approved products and significant price reductions (39–88%) reported for biosimilars of adalimumab, infliximab, and etanercept compared to their RPs. Despite ongoing challenges, the new Argentinian regulations offer promising prospects for future advancements, with expectations that increased regulatory experience, harmonized health policies, and comprehensive pharmacovigilance will refine standards and address existing gaps.