alexa Policy Practices to Maximise Social Benefit from Biosimilars | OMICS International | Abstract
ISSN: 0975-0851

Journal of Bioequivalence & Bioavailability
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Research Article

Policy Practices to Maximise Social Benefit from Biosimilars

Inotai A1,2*, Csanádi M1,3, Vitezic D4, Francetic I5, Tesar T6, Bochenek T7, Lorenzovici L8,9, Dylst P10 and Kaló Z1,2

1Syreon Research Institute, Budapest, Hungary

2Department of Health Policy and Health Economics, Eötvös Loránd University (ELTE), Budapest, Hungary

3Department of Pharmaceutics and Central Clinical Pharmacy, University of Pécs, Pécs, Hungary

4University of Rijeka School of Medicine and University Hospital Centre Rijeka, Rijeka, Croatia

5Center for Expert Medicine, Zagreb, Croatia

6Department of Organisation and Management in Pharmacy, Comenius University in Bratislava, Bratislava, Slovakia

7Department of Drug Management, Institute of Public Health, Jagiellonian University Medical College, Krakow, Poland

8Syreon Research Romania, Tirgu Mures, Romania

9Faculty of Technical and Human Sciences, Sapientia University, Tirgu Mures, Romania

10Biosimilar Medicines Group, Medicines for Europe, Brussels, Belgium

*Corresponding Author:
Inotai A, PharmD, PhD
Syreon Research Institute
Hungary-1142, Budapest
Mexikói Str. 65/A, Hungary
Tel: +36-1-787-0083
Fax: +36- 1-220-5768
E-mail: [email protected]

Received Date: June 20, 2017; Accepted Date: July 07, 2017; Published Date: July 17, 2017

Citation: Inotai A, Csanádi M, Vitezic D, Francetic I, Tesar T, et al. (2017) Policy Practices to Maximise Social Benefit from Biosimilars. J Bioequiv Availab 9:467-472. doi: 10.4172/jbb.1000346

Copyright: © 2017 Inotai A, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


Biosimilar medicines can generate savings to the society. However, if patient access to original biologic medicines is limited, the main benefit of biosimilar medicines is to treat more patients from the same health care budget and hence generate more health gain.

The aim of this policy paper is to provide recommendations on how to maximise the value proposition of biosimilar medicines in lower income countries with more limited health care resources.

From the clinical perspective, first line use of multi-source, off-patent biologics should be considered for all treatment naïve patients before prescribing any other patented biologic therapies without major added benefit. Systematic literature reviews indicate that significant and quantifiable economic benefits from switching patients on maintenance biologic to biosimilars should not be sacrificed for non-quantifiable and fairly low risks of immunogenicity, hence a single switch of patients from an original biologic to its biosimilar alternative under medical supervision should be mandated after patent expiry.

From the health economic perspective authors advocate the use of cost-utility analysis to evaluate the full economic value of biosimilars. In sensitivity analyses decision-makers can explore the level of risk associated with immunogenicity, where switch of patients treated by original biologics is not the preferred policy approach anymore. However, authors still advocate the collection of real world pharmacovigilance data after switching patients to biosimilars, and reassessment of cost-effectiveness ratio after more real-world data becomes available.

Appropriateness of biosimilar drug policies is equally important to market access of new biologic therapies in lower income countries.


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