open access

Vol 13, No 6 (2017)
Guidelines / Expert consensus
Published online: 2018-01-04
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Polish Society of Clinical Oncology position statement on the urgent need of introduction of national standards for utilization of biologic drugs

Piotr J. Wysocki, Maciej Krzakowski, Jan Walewski, Monika Duszyńska, Marek Z. Wojtukiewicz, Dariusz Kowalski, Rafał Zyśk
DOI: 10.5603/OCP.2017.0037
·
Oncol Clin Pract 2017;13(6):259-263.

open access

Vol 13, No 6 (2017)
EXPERTS' OPINION
Published online: 2018-01-04

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.

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.
Get Citation

Keywords

biosimilar drugs, monoclonal antibodies, substitution, Polish Society of Clinical Oncology

About this article
Title

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

Journal

Oncology in Clinical Practice

Issue

Vol 13, No 6 (2017)

Article type

Guidelines / Expert consensus

Pages

259-263

Published online

2018-01-04

DOI

10.5603/OCP.2017.0037

Bibliographic record

Oncol Clin Pract 2017;13(6):259-263.

Keywords

biosimilar drugs
monoclonal antibodies
substitution
Polish Society of Clinical Oncology

Authors

Piotr J. Wysocki
Maciej Krzakowski
Jan Walewski
Monika Duszyńska
Marek Z. Wojtukiewicz
Dariusz Kowalski
Rafał Zyśk

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