Evidence from over 10 years of clinical experience demonstrates that biosimilar medicines approved in the European Union can be used for all their registered indications as safely as their originators and with no negative impact on therapeutic efficacy. The debate on the use of biosimilars in rheumatology focuses specifically on the safety of switching between biosimilars and reference products. Studies conducted to date, including randomised double-blind and open-label extension trials, have not demonstrated any significant differences in therapeutic efficacy or safety between patients switched from one medicine to another and those who were continued on a single medicine. According to the latest recommendations for the use of biosimilars in rheumatic diseases, developed by an international task force in 2017, there is no clinical evidence that a single switch from an originator to a biosimilar medicine is associated with any significant risk for patient safety or reduction in therapeutic efficacy.

Piotr Wiland

Bogdan Batko

Marek Brzosko

Eugeniusz Kucharz

Włodzimierz Samborski

Jerzy Świerkot

Ewa Więsik-Szewczyk

Julia Feldman

Reumatologia/Rheumatology

Rheumatology

Biosimilar switching – current state of knowledge

There is no clinical evidence that a single switch from an originator to a biosimilar medicine is associated with any significant risk for patient safety or reduction in therapeutic efficacy, according to the latest recommendations for the use of biosimilars in rheumatic diseases.

生物类似药转换——当前知识现状

Category	Quartile
医学	2
医学, 风湿病学	2

Biosimilar switching – current state of knowledge

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