<abstract xmlns="http://www.w3.org/1999/xhtml"><p><bold>Introduction:</bold> Biology therapies in a various medical specializations and for a broad spectrum of indications were launched during last two decades. As a new in class the therapies were obliged to provide additional data re gar ding efficacy and safety after their real medical practice integration. Patient registries, databases collecting various patient data, were introduced to grant data on the treatment effectiveness, safety, and long-term on treatment survival. Satisfactory treatment effect and acceptable safety profile were confirmed after couple of years of careful observation. However, the benefits were usually offered at much higher treatment costs compared to the standard therapies. Biologically similar drugs, so-called biosimilars (B.S), are being launched after original molecule patent protection expiry during recent years. They were expected as an ideal solution to avoid distinct impact on the medical budget: comparable effect for less money. The unsubstantiated doubts about biosimilar efficacy and safety were the reason of the late launch in many markets. Since biosimilars are considered as new therapy entities, the cautiousness to certain extent should be required. Information gained from post-marketing observations and patient registries over several years, confirmed the biosimilar product comparable quality. Healthcare budget savings could secure easier therapy access for more new patients.</p></abstract>

Introduction: Biology therapies in a various medical specializations and for a broad spectrum of indications were launched during last two decades. As a new in class the therapies were obliged to provide additional data re gar ding efficacy and safety after their real medical practice integration. Patient registries, databases collecting various patient data, were introduced to grant data on the treatment effectiveness, safety, and long-term on treatment survival. Satisfactory treatment effect and acceptable safety profile were confirmed after couple of years of careful observation. However, the benefits were usually offered at much higher treatment costs compared to the standard therapies. Biologically similar drugs, so-called biosimilars (B.S), are being launched after original molecule patent protection expiry during recent years. They were expected as an ideal solution to avoid distinct impact on the medical budget: comparable effect for less money. The unsubstantiated doubts about biosimilar efficacy and safety were the reason of the late launch in many markets. Since biosimilars are considered as new therapy entities, the cautiousness to certain extent should be required. Information gained from post-marketing observations and patient registries over several years, confirmed the biosimilar product comparable quality. Healthcare budget savings could secure easier therapy access for more new patients.

Biosimilar medicines and patient registries – expectations, limitations, and opportunities

Dermatovenerology Clinic, Jessenius Faculty of Medicine in Martin

Comenius University in Bratislava, University Hospital

Acta Medica Martiniana

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

Introduction: Biology therapies in a various medical specializations and for a broad spectrum of indications were launched during last two decades. As a new in...

Biosimilar medicines and patient registries – expectations, limitations, and opportunities

Published Online: Feb 20, 2018

Page range: 39 - 51

Received: Jan 01, 2018

Accepted: Jan 26, 2018

DOI: https://doi.org/10.1515/acm-2017-0016

Keywords
biology therapy registries, biosimilars, biologically similar drugs, HTA (health technology assessment)

© 2017 Sutka R et al., published by De Gruyter Open

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

Biosimilar medicines and patient registries – expectations, limitations, and opportunities

Published Online: Feb 20, 2018

Page range: 39 - 51

Received: Jan 01, 2018

Accepted: Jan 26, 2018

DOI: https://doi.org/10.1515/acm-2017-0016

Keywordsbiology therapy registries, biosimilars, biologically similar drugs, HTA (health technology assessment)

© 2017 Sutka R et al., published by De Gruyter Open

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

Keywords
biology therapy registries, biosimilars, biologically similar drugs, HTA (health technology assessment)