<abstract xmlns="http://www.w3.org/1999/xhtml"><p>The use of biological medicine has significantly increased in recent decades and has made substantial contributions to improving the effectiveness of therapies in many diseases. The expiration of patents of biological innovative medicines enables copies of those drugs called similar biological products (biosimilars) to be approved by regulatory authorities and to enter in clinical use. Biosimilars are comparable but not identical and are not a generic version of the innovator biological product. Although biosimilars undergo rigorous characterization as well as clinical studies to prove their safety and effectiveness, specific regulatory requirements for registration apply in the case of biosimilars. They are highly complex molecules and small changes in the production process can have major implications in its safety and effectiveness profile. The availability of biosimilars enhances competition, with the potential to improve patient access to biological medicines and to contribute to the financial sustainability of healthcare systems. In order to be certain that a biosimilar reaches its potential in clinical use, an intensive pharmacovigilance monitoring system must be established in order to prove the true similarity between the original biologic and its biosimilar. There is a need for further guidance and resolution of the ongoing discussions on biosimilar labelling, naming, pharmacovigilance and substitution in order to ensure effective and appropriate use of biosimilars in clinical practice.</p></abstract>

The use of biological medicine has significantly increased in recent decades and has made substantial contributions to improving the effectiveness of therapies in many diseases. The expiration of patents of biological innovative medicines enables copies of those drugs called similar biological products (biosimilars) to be approved by regulatory authorities and to enter in clinical use. Biosimilars are comparable but not identical and are not a generic version of the innovator biological product. Although biosimilars undergo rigorous characterization as well as clinical studies to prove their safety and effectiveness, specific regulatory requirements for registration apply in the case of biosimilars. They are highly complex molecules and small changes in the production process can have major implications in its safety and effectiveness profile. The availability of biosimilars enhances competition, with the potential to improve patient access to biological medicines and to contribute to the financial sustainability of healthcare systems. In order to be certain that a biosimilar reaches its potential in clinical use, an intensive pharmacovigilance monitoring system must be established in order to prove the true similarity between the original biologic and its biosimilar. There is a need for further guidance and resolution of the ongoing discussions on biosimilar labelling, naming, pharmacovigilance and substitution in order to ensure effective and appropriate use of biosimilars in clinical practice.

Biosimilar medical products – licensing, pharmacovigilance and interchangeability

Pharmaceutical Chemistry Institute, Faculty of Pharmacy, Ss. Cyril and Methodius University, Skopje, R. Macedonia

PRILOZI

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

The use of biological medicine has significantly increased in recent decades and has made substantial contributions to improving the effectiveness of therapies...

Biosimilar medical products – licensing, pharmacovigilance and interchangeability

Published Online: Jul 15, 2016

Page range: 27 - 36

DOI: https://doi.org/10.1515/prilozi-2016-0006

Keywords
Regulatory, biosimilars, biologics, licensing, interchangeability, pharmacovigilance, EMA

© 2016 Aleksandra Grozdanova et al., published by De Gruyter Open

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Biosimilar medical products – licensing, pharmacovigilance and interchangeability

Published Online: Jul 15, 2016

Page range: 27 - 36

DOI: https://doi.org/10.1515/prilozi-2016-0006

KeywordsRegulatory, biosimilars, biologics, licensing, interchangeability, pharmacovigilance, EMA

© 2016 Aleksandra Grozdanova et al., published by De Gruyter Open

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Keywords
Regulatory, biosimilars, biologics, licensing, interchangeability, pharmacovigilance, EMA