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