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

• Published in: Acta medica martiniana Vol. 17; no. 3; pp. 39 - 51
• Main Authors: Sutka, R, Pec, J, Pecova, T
• Format: Journal Article
• Language: English
• Published: Martin De Gruyter Open 01-12-2017; De Gruyter Poland; Sciendo
• Subjects: Biological products; biologically similar drugs; biology therapy registries; biosimilars; Clinical outcomes; Drug therapy; Health informatics; Health technology assessment; HTA (health technology assessment); Patients
• ISSN: 1335-8421; 1335-8421; 1338-4139
• DOI: 10.1515/acm-2017-0016

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.