alexa Pharmacovigilance for Biosimilars
ISSN: 2329-6887

Journal of Pharmacovigilance
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Review Article

Pharmacovigilance for Biosimilars

Maria I Karampola1,2* and Christos E Emmanouilides 1
1Interbalkan Medical Center, Department of Oncology, Asklipiou 10, Pylaia, 57001, Greece
2Oncologic Office, D.Gounari 35, Thessaloniki, 54622, Greece
Corresponding Author : Maria I Karampola
El. Venizelou 26, Chalastra, Thessaloniki
Post Code: 57 300, Greece
Tel: 306976157798
E-mail: [email protected]
Received: February 03, 2016; Accepted:February 17, 2016;Published: February 22, 2016
Citation: Karampola MI, Emmanouilides CE (2016) Pharmacovigilance for Biosimilars. J Pharmacovigil 4:196. doi:10.4172/2329-6887.1000196
Copyright: © 2016 Karampola MI, 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.


Pharmacovigilance can be defined as the process of collection of safety and to a lesser extent efficacy information regarding pharmaceuticals that have already been launched in the market. It is possible that all toxicity has not been precisely identified before drugs obtain approval for marketing. In addition to relying in ad hoc toxicity reporting, formal studies may be conducted after drug approval to confirm safety (post-authorization safety study, PASS), as well as efficacy (post-authorization efficacy study, PAES). These studies are of paramount importance for biosimilars, due to their macromolecular and potential immunogenic nature. Biosimilars are used in many medical fields, including oncology and rheumatology.

In order to guarantee the success of post-authorization studies, both health care professionals and patients are required to contribute by reporting adverse drug reactions (ADR). The European Union even urges patients to directly report ADR. Apart from physicians, pharmacists play an important role in pharmacovigilance, by keeping accurate records enabling the identification of a specific batch of a biosimilar to be linked to a particular ADR. Thus the principle of non-inter changeability of the prescribed product ought to be followed. PASS are mandatory for biosimilars at the responsibility of the market authorization holder. Implementation of rigorous pharmacovigilance policies will promote physicians' confidence in them, hopefully resulting in financial alleviation of Health Systems.


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