Biological medicines are essential for many acute and chronic conditions [
[1]
]. A biosimilar is a version similar to an authorized original biological product with
clinical comparability that must be demonstrated in terms of quality, biological activity,
safety and efficacy [
[2]
]. The consumption of biosimilar medicines differs widely among European countries.
Germany has the highest use of biosimilars in Europe, with around 50% volume uptake.
Despite initial resistance, Italy and Spain are now catching up and the uptake of
biosimilars is increasing [
[3]
], but concerns about efficacy, safety and interchangeability with reference products
are frequently expressed by specialists and position papers [
4
,
5
].Keywords
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References
- Clinical considerations for biosimilar antibodies.EJC Suppl. 2013 Dec; 11: 1-11
- GaBI online — use of biosimilars in Europe differs across countries.(Available from:)
- Scientific guidelines on biosimilar medicines.([Accessed on May, 2016])
- The use of biosimilars in immune-mediated disease: a joint Italian Society of Rheumatology (SIR), Italian Society of Dermatology (SIDeMaST), and Italian Group of Inflammatory Bowel Disease (IG-IBD) position paper.Autoimmun Rev. 2014 Jul; 13: 751-755
- New frontiers in oncology: biosimilar monoclonal antibodies for the treatment of breast cancer.Expert Rev Anticancer Ther. 2015 Mar; 15: 331-338
- Switching from originator to biosimilar human growth hormone using dialogue teamwork: single-center experience from Sweden.Biol Ther. 2013; 3: 35-43
- Effect of switching recombinant human growth hormone: comparative analysis of phase 3 clinical data.Biol Ther. 2011 Dec 16; 1: 5
- Are biosimilars interchangeable?.([Accessed on May 20, 2016])
- Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study.Ann Rheum Dis. 2016 Apr 26; ([pii: annrheumdis-2015-208783])
- Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study.Ann Rheum Dis. 2016; 29 ([pii: annrheumdis-2015-208786])
Article Info
Publication History
Published online: July 23, 2016
Accepted:
July 13,
2016
Received:
July 11,
2016
Identification
Copyright
© 2016 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.
