Different pharmaceutical products need similar terminology.
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.
Department of Pharmaceutical Sciences, Utrecht University, P.O. Box 80.082, 3508 TB, Utrecht, The Netherlands.
Daan J A
DJ
Crommelin
Jon S B
JS
de Vlieger
Vera
V
Weinstein
Stefan
S
Mühlebach
Vinod P
VP
Shah
Huub
H
Schellekens
D001688:Biological Products; D016568:Drugs, Generic; D009626:Terminology as Topic
D001688:Biological Products; D016568:Drugs, Generic