Polish Society of Clinical Oncology position statement on the urgent need of introduction of national standards for utilization of biologic drugs

Abstract

Biosimilar anti-cancer monoclonal antibodies will be introduced into clinical practice in 2018. The
advent of anti-cancer biosimilars may lead to reduction of the global costs of cancer treatment, diminish the current limitations related to biological drugs and improve the optimization of cancer
therapy. However, one has to realize that biosimilar drugs are not generics, and cancer treatment
based on biological (biosimilar) drugs should follow stringent rules. One of the most important
general rules is the prohibition of automatic substitution of biological drugs without clinical indications. In the face of introduction of biosimilars, the majority of EU countries, but not Poland, has
generated national standards for the utilization of biologic drugs, along with lists of drugs which can undergo automatic substitution. Lack of such regulations in Poland may complicate effective and safe utilization of anti-cancer biological agents in the era of biosimilars.