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Journal of Health Policy & Outcomes Research, 1, p. 56-65, 2014

DOI: 10.7365/jhpor.2014.5.7

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The Polish Expert Group Position Statement on the safety of biological treatments with monoclonal antibodies and fusion proteins

This paper was not found in any repository; the policy of its publisher is unknown or unclear.
This paper was not found in any repository; the policy of its publisher is unknown or unclear.

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Abstract

Objective: The first biological therapeutics have already reached their patent expiration dates and corresponding biosimilars have been approved by the EMA and FDA. The approval of products similar, but not identical to already known innovative biologics is stirring a lot of debate about safety concerns, as well as the relevance of these differences to clinical practice. Methods: A Group of 13 experts involved in various aspects of biological therapies in Poland was established. Modified Delphi method of voting was performed to achieve consensus regarding the most important aspects of biological treatment in Poland, with particular concern regarding biosimilars. Results: Ten final statements were discussed and voted upon. The statements cover general aspects of biosimilars, including expected cost-benefit ratios, extrapolation of clinical indications, interchange, switching, patient information and the requirement of patient consent. The state of post-marketing pharmacovigilance of biologicals (innovative ones as well as biosimilars) was also discussed. Conclusions: The Expert Group agreed that introduction of biosimilars is an important achievement in biological therapies, with the potential to reduce treatment costs and increase their availability. Experts also agreed that the safety of biological treatments should be monitored more carefully in Poland. There is an unmet need in Poland for the creation of a registry collecting data needed for the assessment of safety and efficacy of both biosimilars and their reference products in accordance with the experience and principles introduced in other European countries.