Current status of biopharmaceuticals in Iran’s pharmaceutical market
Journal Title: Generics and Biosimilars Initiative Journal - Year 2013, Vol 2, Issue 1
Abstract
The clinical importance of biopharmaceuticals for the management of life threatening diseases is increasing but costs have become a major obstacle to the administration of these medicines, especially in resource limited healthcare systems. Introduction of biosimilars as a cost-effective alternative to innovator biopharmaceuticals has attracted the attention of both industry and policymakers. However, due to the complex structures of biopharmaceuticals, the regulation of biosimilars has become challenging for national regulatory authorities. In the past decade, national pharmaceutical companies in Iran have manufactured copies of several brand-name biopharmaceuticals. Although copied biopharmaceuticals produced by Iranian companies have received marketing authorization for the local market, none has been evaluated using internationally recognized guidelines for the approval of biosimilars. Therefore, effective pharmacovigilance programmes are essential to evaluate whether the safety and efficacy profiles of these locally produced biopharmaceuticals are different from those of either the original brand biopharmaceuticals or their biosimilar versions.
Authors and Affiliations
Abdol Majid Cheraghali
Keywords
Related Articles
- EP ID EP355095
- DOI 10.5639/gabij.2013.0201.008
- Views 114
- Downloads 0
Ongoing initiatives in the Republic of Srpska to enhance prescribing efficiency; influence and future directions
Dr Brian Godman reviews the paper by Markovic-Pekovic et al. regarding recent reforms in the Republic of Srpska. These include prescribing restrictions where concerns with the value of products and measures to obtain low...
Suggested evaluation of biological drugs role for WHO – Editor’s response
The Editor-in-Chief expresses his concerns about the proposal of a WHO run system to approve copy biologicals in the Milani and Gaspani paper [1].
Health authority perspective on biosimilars
Dr Brian Godman reviews Mr Gustaf Befrits’ paper on the case for biosimilars from a payer’s perspective. Biosimilars are increasingly important to payers with growing resource pressures. However, key issues need addressi...
Rhythm
Clinical biosimilar data should be accessible to all Calls are growing for biosimilar manufacturers to publish their data in the public domain, particularly when developing versions of monoclonal antibodies that are asso...
PMDA update: the current situation and future directions
The Pharmaceuticals and Medical Devices Agency (PMDA) is a Japanese drug regulatory agency, sharing responsibilities with the Ministry of Health, Labour and Welfare. Its mission is to protect the public health by assurin...