Biosimilars – What Does It Mean?

DOI: 10.3238/zfa.2010.0

german translation / full article

Ursula Gundert-Remy

Keywords: biosimilars side effects therapeutic efficacy

Abstract: Biosimilars contain a biotechnologically produced protein, which is structurally similar to an original product with identical pharmacological effects already licensed in European Union. To meet ongoing discussions about drug safety of biosimilars regulatory documents about pharmaceutical quality and pharmacologic-toxicological and clinical investigations in comparison to the reference product were screened. Based on this documentation one can conclude that biosimilars are as effective as the originator product. Careful control is advised when switching a patient from the originator to a biosimilar product. With respect to safety the situation is similar to the administration of a newly approved drug with a drug molecule belonging to the same pharmacological class with a known spectrum of side effects.

(State: 30.05.2011)

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