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.

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.

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