Pragmatic rules for comparability of biological medicinal products

被引:9
作者
van der Plas, R. Martijn [1 ]
Hoefnagel, Marcel H. N. [1 ]
Hillege, Hans L. [1 ,2 ]
Roes, Kit C. B. [1 ,3 ]
机构
[1] Med Evaluat Board Netherlands, Utrecht, Netherlands
[2] Univ Med Ctr Groningen, Dep Cardiol & Epidemiol, Groningen, Netherlands
[3] Radboud Univ Nijmegen, Med Ctr, Sect Biostat, Dept Hlth Evidence, Nijmegen, Netherlands
关键词
Comparability; Comparability exercise; Biologicals; Biological; Medicinal products; Biosimilarity; Biosimilar; Statistics; Methodology;
D O I
10.1016/j.biologicals.2019.11.002
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
Comparability is a key concept in the evaluation of both manufacturing changes and biosimilars. It constitutes a pragmatic and flexible approach which recognises that biologicals are inherently variable and that minor variations in quality attributes are often clinically irrelevant. In this discussion paper, we argue that comparability exercises rely on a number of pragmatic criteria. These criteria have been remarkably robust for 20 years of comparability exercises; however, the increased scrutiny of biosimilar applications provides an impetus for both codification and improvement of criteria for establishing comparability. Such a more rigorous, methodologically sound, approach towards comparability seems both feasible and beneficial.
引用
收藏
页码:97 / 100
页数:4
相关论文
共 50 条
[41]   DRUG DELIVERY SYSTEMS USED FOR BIOLOGICAL PRODUCTS [J].
Saka, Ongun Mehmet .
JOURNAL OF RESEARCH IN PHARMACY, 2023, 27 :4-6
[42]   Regulatory Prototype for Biological Products in the United States [J].
Pavithra, G. M. ;
Venugopal, N. .
JOURNAL OF PHARMACEUTICAL RESEARCH INTERNATIONAL, 2021, 33 (28B) :60-72
[44]   Evaluating the Impact of Two Biological Products on Soil Biological Health and Turfgrass Quality [J].
Winniefred Griffin ;
Mussie Habteselassie ;
Alfredo D. Martinez-Espinoza ;
Paul Raymer ;
Henry Sintim ;
Svoboda Pennisi .
Water, Air, & Soil Pollution, 2023, 234
[45]   Evaluating the Impact of Two Biological Products on Soil Biological Health and Turfgrass Quality [J].
Griffin, Winniefred ;
Habteselassie, Mussie ;
Martinez-Espinoza, Alfredo D. ;
Raymer, Paul ;
Sintim, Henry ;
Pennisi, Svoboda .
WATER AIR AND SOIL POLLUTION, 2023, 234 (10)
[46]   Application of magnetic field and iron in order to change medicinal products of Ocimum basilicum [J].
Ghanati F. ;
Abdolmaleki P. ;
Vaezzadeh M. ;
Rajabbeigi E. ;
Yazdani M. .
The Environmentalist, 2007, 27 (4) :429-434
[47]   Giving Information on Medicinal Products to the General Public - In Search of a Definition to Safeguard the Patient [J].
Faeh, Andrea .
EUROPEAN JOURNAL OF HEALTH LAW, 2014, 21 (02) :176-195
[48]   The Proposed EU-regulation on Clinical Trials on Medicinal Products: An Unethical Proposal? [J].
Heringa, Jilles ;
Dute, Joseph .
EUROPEAN JOURNAL OF HEALTH LAW, 2013, 20 (04) :347-362
[49]   Extracellular Vesicles as Next-Generation Diagnostics and Advanced Therapy Medicinal Products [J].
Stawarska, Agnieszka ;
Bamburowicz-Klimkowska, Magdalena ;
Runden-Pran, Elise ;
Dusinska, Maria ;
Cimpan, Mihaela Roxana ;
Rios-Mondragon, Ivan ;
Grudzinski, Ireneusz P. .
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES, 2024, 25 (12)
[50]   The role of the Committee for Medicinal Products for Human Use (CHMP) in the European centralised procedure [J].
Enzmann, H. ;
Schneider, C. .
BUNDESGESUNDHEITSBLATT-GESUNDHEITSFORSCHUNG-GESUNDHEITSSCHUTZ, 2008, 51 (07) :731-739