Different Pharmaceutical Products Need Similar Terminology

被引：44

作者：

Crommelin, Daan J. A. ^{[1
]}

de Vlieger, Jon S. B. ^{[2
]}

Weinstein, Vera ^{[3
]}

Muehlebach, Stefan ^{[4
]}

Shah, Vinod P.

Schellekens, Huub ^{[1
,5
]}

机构：

[1] Univ Utrecht, Dept Pharmaceut Sci, NL-3508 TB Utrecht, Netherlands

[2] Dutch Top Inst Pharma, NL-2300 AC Leiden, Netherlands

[3] Teva Pharmaceut Ind, IL-49131 Petah Tiqwa, Israel

[4] Vifor Pharma Ltd, CH-8152 Glattbrugg, Opfikon, Switzerland

[5] Univ Utrecht, Dept Innovat Studies, NL-3508 TB Utrecht, Netherlands

来源：

AAPS JOURNAL | 2014年 / 16卷 / 01期

关键词：

biosimilars; generics; non biological complex drugs; substitution; terminology;

D O I：

10.1208/s12248-013-9532-0

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

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.

引用

页码：11 / 14

页数：4

共 9 条

[1]

[Anonymous], SCI CONS DEM BIOS RE

[2]

[Anonymous], QUAL CONS DEM BIOS R

[3]

[Anonymous], 2009, Guidelines on evaluation of similar biotherapeutic products (SBPs)

[4] Nanoparticle iron medicinal products - Requirements for approval of intended copies of non-biological complex drugs (NBCD) and the importance of clinical comparative studies [J].

Borchard, Gerrit ;

Fluhmann, Beat ;

Muhlebach, Stefan .

REGULATORY TOXICOLOGY AND PHARMACOLOGY, 2012, 64 (02) :324-328

[5]

Chow S.C., 2011, Biosimilars, V1, P13, DOI DOI 10.2147/BS.S20577

[6]

Ehmann F, 2013, NANOMEDICINE-UK, V8, P849, DOI [10.2217/NNM.13.68, 10.2217/nnm.13.68]

[7]

Konski AF, 2011, BIOPROCESS INT, V9, P34

[8] The therapeutic equivalence of complex drugs [J].

Schellekens, Huub ;

Klinger, Ety ;

Muehlebach, Stefan ;

Brin, Jean-Francois ;

Storm, Gert ;

Crommelin, Daan J. A. .

REGULATORY TOXICOLOGY AND PHARMACOLOGY, 2011, 59 (01) :176-183

[9] Biosimilars-why terminology matters [J].

Weise, Martina ;

Bielsky, Marie-Christine ;

De Smet, Karen ;

Ehmann, Falk ;

Ekman, Niklas ;

Narayanan, Gopalan ;

Heim, Hans-Karl ;

Heinonen, Esa ;

Ho, Kowid ;

Thorpe, Robin ;

Vleminckx, Camille ;

Wadhwa, Meenu ;

Schneider, Christian K. .

NATURE BIOTECHNOLOGY, 2011, 29 (08) :690-693

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