Biosimilar epoetins and other "follow-on" biologics: update on the European experiences.

Abstract:

: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.

journal_name

Am J Hematol

authors

Jelkmann W

doi

10.1002/ajh.21805

subject

Has Abstract

pub_date

2010-10-01 00:00:00

pages

771-80

issue

10

eissn

0361-8609

issn

1096-8652

journal_volume

85

pub_type

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