The use of biosimilars in hematooncology - Position statement of the Polish Society of Hematology and Transfusion Medicine

Abstract

Biosimilar drugs play an increasing role in the therapy of many diseases due to the expiry of patent protection for many biologicals. In this manuscript, we describe the issues regarding the definition, approval and use of biosimilars focusing on the ones that are used in hematology. We discuss the aspects of extrapolation, interchangeability, switching and automatic substitution. The statement of the Polish Society of Hematology and Transfusion Medicine is based on the of EMA (European Medicines Agency) guidelines and the position paper of the ESMO (European Society of Medical Oncology).