title: Clinical considerations for biosimilar antibodies.
abstract: Biosimilar agents are approximate copies of branded biologic therapies. Since the first biosimilar was authorized in the European Union in 2006, fifteen additional agents have been approved by the European Medicines Agency, including two biosimilar monoclonal antibodies (mAbs). Biosimilar mAbs represent a distinct class given their large molecular size, complex protein structure, and post-translational modifications. While guidelines have been established for the development, approval, and use of biosimilars, further scrutiny and discussion is necessary to fully understand their potential impact on clinical outcomes. This review takes a critical look at the structural complexity of biosimilar mABs, the feasibility of indication extrapolation, the impact of product variability on immunogenicity, the importance of comprehensive pharmacovigilance, and the potential for ongoing pharmacoeconomic impact.
authors.affiliation: Professor of Oncological Biotherapy, Department of Oncology-Pathology, Karolinska Institute, SE-171 76 Stockholm, Sweden.
authors.forename: Håkan
authors.initials: H
authors.lastname: Mellstedt
keywords: Biologic; Biosimilar; Extrapolation; Immunogenicity; Monoclonal antibody; Pharmacoeconomics; Pharmacovigilance