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Different pharmaceutical products need similar terminology

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Publication date

2014-01

Authors

Crommelin, DaanISNI 0000000115782349
de Vlieger, Jon S B
Weinstein, Vera
Mühlebach, Stefan
Shah, Vinod P
Schellekens, HuubISNI 0000000115645352

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DOI

https://doi.org/10.1208/s12248-013-9532-0

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Article

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Utrecht University Repository

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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.

Keywords

Biological Products, Drugs, Generic, Terminology as Topic

Citation

Crommelin, D J A, de Vlieger, J S B, Weinstein, V, Mühlebach, S, Shah, V P & Schellekens, H 2014, 'Different pharmaceutical products need similar terminology', The AAPS journal, vol. 16, no. 1, pp. 11-4. https://doi.org/10.1208/s12248-013-9532-0

URI

https://dspace.library.uu.nl/handle/1874/308402