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. 2014 Jan;16(1):11-4.
doi: 10.1208/s12248-013-9532-0. Epub 2013 Sep 25.

Different pharmaceutical products need similar terminology

Daan J A Crommelin  1 , Jon S B de Vlieger, Vera Weinstein, Stefan Mühlebach, Vinod P Shah, Huub Schellekens
Affiliations

Different pharmaceutical products need similar terminology

Daan J A Crommelin et al. AAPS J. 2014 Jan.

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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