Biosimilar epoetins and other "follow-on'' biologics: Update on the European experiences

被引：70

作者：

Jelkmann, Wolfgang ^{[1
]}

机构：

[1] Univ Lubeck, Inst Physiol, D-23538 Lubeck, Germany

来源：

AMERICAN JOURNAL OF HEMATOLOGY | 2010年 / 85卷 / 10期

关键词：

RED-CELL APLASIA; CHRONIC KIDNEY-DISEASE; ERYTHROPOIESIS-STIMULATING AGENTS; RECEPTOR ACTIVATOR CERA; HEMODIALYSIS-PATIENTS; THERAPEUTIC PROTEINS; FEBRILE NEUTROPENIA; POSITION STATEMENT; REGULATORY ACTIONS; DARBEPOETIN-ALPHA;

D O I：

10.1002/ajh.21805

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

After the patents of biopharmaceuticals have expired, based on specific regulatory approval pathways copied products ("biosimilars'' or "follow-on biologics'') have been launched in the EU. This article summarizes experiences with hematopoietic medicines, namely the epoetins (two biosimilars traded under five different brand names) and the filgrastims (two biosimilars, six brand names). Physicians and pharmacists should be familiar with the legal and pharmacological specialities of biosimilars: The production process can differ from that of the original, clinical indications can be extrapolated, glycoproteins contain varying isoforms, the formulation may differ from the original, and biopharmaceuticals are potentially immunogenic. Only on proof of quality, efficacy and safety, biosimilars are a viable option because of their lower costs. Am. J. Hematol. 85:771-780, 2010. (C) 2010 Wiley-Liss, Inc.

引用

页码：771 / 780

页数：10

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