GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 2 / Year 2013 / Issue 4
Editorial
Do low- to middle-income countries need a biosimilar approval pathway based on a full comparability exercise?
Author(s): Armando A Genazzani, DPhil, MD, Nicola Magrini, MD
Page: 163-4Abstract: Despite the fact that hepatitis C is a disease of global importance, many countries cannot afford the costly but effective combination treatment of peg-interferon and ribavirin, which was recently included in the World Health Organization Essential Medicines List. Given that peg-interferon is a biotechnological product, should low- to middle-income countries adopt the burdensome biosimilar […]
Suggested evaluation of biological drugs role for WHO – Editor’s response
Author(s): Professor Philip D Walson, MD
Page: 162Abstract: 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]. The paper by Milani and Gaspani [1] suggests that the World Health Organization (WHO) sets up a programme to approve follow-on pegylated interferons and similar biological medications, that is biological […]
