Acta Scientific Pharmacology

Review Article Volume 1 Issue 7

Biosimilars: An European Overview

Anna Ponzianelli, Nicolo’ Bendinelli*, Cristina Vilei, Annalaura Giorgio, Roberta Laurita, Diletta Schito, Umberto Finelli, Nicoletta Martone, Viviana Ruggeri, Valeria Viola and Enrico Bosone

SIARV, Società Italiana Attività Regolatorie, Accesso, Farmacovigilanza, Via della Rocchetta, Pavia, Italy

*Corresponding Author: Nicolo’ Bendinelli, SIARV Società Italiana Attività Regolatorie, Accesso e Farmacovigilanza, Via Antonio Salandra, Rome, Italy.

Received: May 28, 2020; Published: June 11, 2020



Biosimilar drugs represent the possibility to improve patient access to medicines but also alleviate financial burden faced by stakeholders in the currently constrained European budgetary environment. We reviewed key drivers and policies of biosimilar uptake in Europe, underlying national authorization pathways, timing and strategies. National healthcare systems features as well as physicians prescribing culture, have been featured resulting in a deep heterogeneity and in various policies referable to three main areas: pricing, reimbursement and demand. Unlike Italy and UK, where incentives for prescribers are planned at regional level, France and Germany extended them nationally. There are now substantial evidences of a common reduced familiarity with biosimilar drugs in countries where substitution is not allowed. To date, Germany, Spain, Portugal, Sweden, Norway, Finland, Austria, Holland, Czech Republic, Hungary and Romania introduced rules to avoid or limit automatic substitution by the pharmacy without physician consent. We evaluated where and why awareness-rising initiatives could be more adequate if tailored on physicians rather than on poorly informed patients. Furthermore, being an extensively mentioned issue within scientific community, we focused on biosimilar pre and post marketing risk/benefit profile assessment. No Regulatory Agencies requires clinical studies to confirm the originator maintained pharmacological characteristics over time or after major variations in productive process. Based on November 2019 European Commission ‘Health and Food Safety Directorate working Group’ discussion, a final commentary on the predictable increment of biosimilar duplicate marketing authorizations is given.

Keywords: Biosimilar; Access; Sustainability; Pricing; Market Penetration; Policy



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Citation: Nicolo’ Bendinelli., et al. “Biosimilars: An European Overview".Acta Scientific Pharmacology 1.7 (2020): 06-13.


Acceptance rate36%
Acceptance to publication20-30 days

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