open access

Vol 3, No 3 (2007)
Review paper
Published online: 2007-05-24
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Original biotechnology medicines and biosimilars - what one should know to provide safety of treatment?

Michał Nowicki, Joanna Zimmer-Nowicka
Onkol. Prak. Klin 2007;3(3):120-127.

open access

Vol 3, No 3 (2007)
REVIEW ARTICLES
Published online: 2007-05-24

Abstract

Biotechnology medicines play a major role in modern pharmacotherapy. They have already helped to fight many diseases which were recognized as incurable in the previous era of conventional chemical drugs. Oncology remains one of the leading areas for the current and future clinical application of biotechnology medicines. Biotech drugs are generally safe and well-tolerated and adverse reactions typical for biological products such as immunogenicity are rare. Recently, the expiry of patent protection for many original biotech drugs (including most recombinant growth factors) has led to the development of products known as biosimilars or follow-on-biologics. Detailed regulations for the approval of biosimilar products have been recently introduced by the European Medicines Agency (EMEA, in full name: European Agency for the Evaluation of Medicinal Products ) but all European countries, except France and the US, lack the national approval pathways on this new kind of biomedicines. This review provides an introduction to the issue of biosimilars revealing the differences between biosimilars and traditional chemical generics as well as potential problems including safety, pharmacovigilance, automatic substitution, naming, labeling and prescription rules.

Abstract

Biotechnology medicines play a major role in modern pharmacotherapy. They have already helped to fight many diseases which were recognized as incurable in the previous era of conventional chemical drugs. Oncology remains one of the leading areas for the current and future clinical application of biotechnology medicines. Biotech drugs are generally safe and well-tolerated and adverse reactions typical for biological products such as immunogenicity are rare. Recently, the expiry of patent protection for many original biotech drugs (including most recombinant growth factors) has led to the development of products known as biosimilars or follow-on-biologics. Detailed regulations for the approval of biosimilar products have been recently introduced by the European Medicines Agency (EMEA, in full name: European Agency for the Evaluation of Medicinal Products ) but all European countries, except France and the US, lack the national approval pathways on this new kind of biomedicines. This review provides an introduction to the issue of biosimilars revealing the differences between biosimilars and traditional chemical generics as well as potential problems including safety, pharmacovigilance, automatic substitution, naming, labeling and prescription rules.
Get Citation

Keywords

biotechnology; biotech medicines; growth factors; biosilimilars; immunogenicity; pharmacovigilance

About this article
Title

Original biotechnology medicines and biosimilars - what one should know to provide safety of treatment?

Journal

Oncology in Clinical Practice

Issue

Vol 3, No 3 (2007)

Article type

Review paper

Pages

120-127

Published online

2007-05-24

Bibliographic record

Onkol. Prak. Klin 2007;3(3):120-127.

Keywords

biotechnology
biotech medicines
growth factors
biosilimilars
immunogenicity
pharmacovigilance

Authors

Michał Nowicki
Joanna Zimmer-Nowicka

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