Comparing Originator Biologics and Biosimilars: A Review of the Relevant Issues

被引:30
作者
Blandizzi, Corrado [1 ]
Meroni, Pier Luigi [2 ,3 ]
Lapadula, Giovanni [4 ]
机构
[1] Univ Pisa, Div Pharmacol, Dept Clin & Expt Med, Via Roma 55, I-56126 Pisa, Italy
[2] Univ Milan, Dept Rheumatol, 1st G Pini, Milan, Italy
[3] Univ Milan, Dept Clin Sci & Hlth Commun, Milan, Italy
[4] Univ Bari, Dept Emergence Med & Transplantat DETO, Rheumatol Unit, Bari, Italy
关键词
biologics; biosimilars; comparability; manufacturing; regulatory guidance; INFLAMMATORY-BOWEL-DISEASE; RHEUMATOID-ARTHRITIS; NECROSIS-FACTOR; MONOCLONAL-ANTIBODIES; ADALIMUMAB TREATMENT; ANKYLOSING-SPONDYLITIS; INNOVATOR INFLIXIMAB; POSITION STATEMENT; PARALLEL-GROUP; DOUBLE-BLIND;
D O I
10.1016/j.clinthera.2017.03.014
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Purpose: We provide a review of current knowledge on comparability between biosimilars and originator biologics in view of the continuous evolution occurring in this highly dynamic area. Methods: English-language literature indexed in MEDLINE was explored, without time limits, to July 31, 2016, using the terms biosimilar, biotechnologic drug, biologic drug, monoclonal antibody, fusion protein, and anti-tumor necrosis factor. The reference lists of identified articles were examined carefully for additional pertinent publications. Findings: Biological medicines are much more structurally complex and extremely sensitive to manufacturing conditions and therefore more difficult to characterize and produce than small molecule drugs. Even minor changes in manufacturing may lead to significant variations of the cellular systems used for biological production, as well as to differences in the structure, stability, or other quality aspects of the end product, all of which have the potential to affect tolerability and/or efficacy and increase the risk of immune responses. Owing to these issues, specific regulatory guidance on biosimilars is continuously evolving, and there is some disagreement on which studies need to be implemented to approve a biosimilar. According to current literature, the following points on biosimilars deserve consideration: biosimilar development is characterized by global harmonization, although several not fully answered questions remain regarding extrapolation of indications, switching or interchangeability, and tolerability; in patients with rheumatic diseases, the tolerability and efficacy of biosimilars in clinical practice remain to be established; several medical and patient associations have published position papers on biosimilars requesting that safety, efficacy, and traceability be carefully considered; long-term postmarketing studies should be implemented to allow physicians to gain confidence in biosimilars. (C) 2017 Elsevier HS Journals, Inc. All rights reserved.
引用
收藏
页码:1026 / 1039
页数:14
相关论文
共 79 条
[1]  
AAD, 2012, AM AC DERM POS STAT
[2]  
ACR, 2016, AM COLL RHEM POS STA
[3]  
[ACR Committee on Rheumatologic Care ACR], ACR COMM RHEUM CAR A
[4]  
AIFA, 2013, AIFA POS PAP FARM BI
[5]   The INN crowd [J].
不详 .
NATURE BIOTECHNOLOGY, 2013, 31 (12) :1055-1055
[6]  
[Anonymous], 2016, GUID SIM BIOL MED PR
[7]  
[Anonymous], 2015, SCI CONS DEM BIOS RE
[8]  
Argüelles-Arias F, 2013, REV ESP ENFERM DIG, V105, P37, DOI 10.4321/S1130-01082013000100006
[9]  
Atzeni F, 2015, CLIN EXP RHEUMATOL, V33, P1
[10]   Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease [J].
Baert, F ;
Noman, M ;
Vermeire, S ;
Van Assche, G ;
D'Haens, G ;
Carbonez, A ;
Rutgeerts, P .
NEW ENGLAND JOURNAL OF MEDICINE, 2003, 348 (07) :601-608