GaBI Journal publishes four issues in 2013
Journal Title: Generics and Biosimilars Initiative Journal - Year 2013, Vol 2, Issue 4
Abstract
This issue marks the forth and final issue of the second year’s edition of the GaBI Journal. The journal has grown rapidly through the combined efforts of the publisher and her staff, all of the members of the executive editorial board and the international editorial advisory board, our contributors, advertisers and readers for which I would like to express my sincere appreciation.
Authors and Affiliations
Philip D Walson
US state legislation on biosimilars substitution
Despite the fact that US Food and Drug Administration has yet to receive a biosimilars application, many US states have been considering legislation which could potentially limit biosimilars substitution.
Assessing biosimilarity and interchangeability of biosimilar products under the Biologics Price Competition and Innovation Act
Biological (large molecule) drug products are made via living systems and are complex and variable in nature. As a result, generic forms of biological products, also termed biosimilars in the EU or follow-on biologics by...
Analysis of European policy towards generic medicines
In this paper, we provide an overview of a PhD project we undertook on European policy on generic medicines. In the course of our research, we identified various causes for delayed market access of generic medicines and...
Drug shortages hit US oncologists hard
The number of drug shortages in the US has tripled between 2006 and 2012, with drug shortages now affecting most US oncologists and impacting on patient care. There is a need for new guidelines to control drug substituti...
Update on clinical practice guideline on the use of epoetin and darbepoetin in adult patients with cancer
Chemotherapy-induced anaemia can be treated using erythropoiesis-stimulating agents (ESAs), but these can cause serious side-effects including tumour progression, venous thromboembolism, and shorter survival. Following e...