Different pharmaceutical products need similar terminology

Daan J A Crommelin; Jon S B de Vlieger; Vera Weinstein; Stefan Mühlebach; Vinod P Shah; Huub Schellekens

doi:10.1208/s12248-013-9532-0

Different pharmaceutical products need similar terminology

Daan J A Crommelin, Jon S B de Vlieger, Vera Weinstein, Stefan Mühlebach, Vinod P Shah, Huub Schellekens

Pharmaceutics

Research output: Contribution to journal › Article › Academic › peer-review

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.

Original language	English
Pages (from-to)	11-4
Number of pages	4
Journal	The AAPS journal
Volume	16
Issue number	1
DOIs	https://doi.org/10.1208/s12248-013-9532-0
Publication status	Published - Jan 2014

Keywords

Biological Products
Drugs, Generic
Terminology as Topic

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AU - Shah, Vinod P

AU - Schellekens, Huub

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KW - Terminology as Topic

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Different pharmaceutical products need similar terminology

Abstract

Keywords

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