Background: Biosimilars have been used for 15 years in the European Union (EU), and have been shown to reduce costs and increase access to important biological medicines. In spite of their considerable exposure and excellent safety record, many prescribers still have doubts on the safety and interchangeability of biosimilars, especially monoclonal antibodies (mAbs) and fusion proteins.
Objectives: The aim of this study was to analyse the short- and long-term safety and interchangeability data of biosimilar mAbs and fusion proteins to provide unbiased information to prescribers and policy makers.
Via deze link komt u bij het artikel uit Drugs magazine d.d. 30 augustus 2021 van
Pekka Kurki · Sean Barry · Ingrid Bourges · Panagiota Tsantili · Elena Wolff-Holz
met als titel:
Safety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins: A Regulatory Perspective