Different Pharmaceutical Products Need Similar Terminology

Overview

Journal AAPS J

Specialty Pharmacology

Date 2013 Sep 26

PMID 24065599

Citations 16

Authors

Daan J A Crommelin

Jon S B de Vlieger

Vera Weinstein

Stefan Muhlebach

Vinod P Shah

Huub Schellekens

Affiliations

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Abstract

In the last decade, discussions on the development of the regulatory framework of generic versions of complex drugs such as biologicals and non-biological complex drugs have attracted broad attention. The terminology used is far from harmonized and can lead to multiple interpretations of legal texts, reflection papers, and guidance documents regarding market introduction as well as reimbursement. This article describes the meaning of relevant terms in different global regions (Europe, USA, WHO) and offers a proposal for a globally accepted terminology regarding (non-) biological complex drugs.

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References

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