Suggested evaluation of biological drugs role for WHO – Editor’s response
Journal Title: Generics and Biosimilars Initiative Journal - Year 2013, Vol 2, Issue 4
Abstract
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].
Authors and Affiliations
Philip D Walson
Keywords
Related Articles
- EP ID EP354619
- DOI 10.5639/gabij.2013.0204.043
- Views 109
- Downloads 0
Reference pricing systems in Europe: characteristics and consequences
Introduction: A reference pricing system is a system that establishes a common reimbursement level or reference price for a group of interchangeable medicines, i.e. the reference group. This article provides an overview...
The potential of generics policies: more room for exploitation–PPRI Conference Report
Introduction: This Conference Report aims to provide an overview of key results, messages and conclusions of the Pharmaceutical Pricing and Reimbursement Information (PPRI) Conference with regard to generics. Methods: Th...
ICH Q11: development and manufacture of drug substances–chemical and biotechnological/biological entities
The International Conference on Harmonisation (ICH) has endorsed a new guideline concerning the development and manufacture of chemical and biotechnological/biological drug substances. The guideline harmonises the scient...
Immunogenicity of biosimilar monoclonal antibodies
Biosimilar monoclonal antibodies (mAbs) are making their way onto the drug market. Because these are complex molecules in terms of structure and function, assessing similarity between originator and biosimilar mAb is cha...
Safety and toxicity of biosimilars—EU versus US regulation
Background: As patents for biological drugs begin to expire, the need for scientific guidance on biosimilar drugs grows increasingly important. The European Medicines Agency provided the first guidelines to cover the app...