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
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...
Do low- to middle-income countries need a biosimilar approval pathway based on a full comparability exercise?
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 H...
Current status of biopharmaceuticals in Iran’s pharmaceutical market
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...
The potential for doctors to contribute to biosimilar guidelines
Many healthcare professionals remain concerned about the safety and efficacy of biosimilars, and are hence reluctant to prescribe them for patients, despite the publication of guidelines for their approval by European re...
Steps to ensure adequate supply of biological medicines: considerations for the healthcare provider
Introduction: When drug shortages occur, healthcare providers (HCPs) often must ration drugs, cancel or delay treatments, or utilize alternative drugs that may be less efficacious and/or are associated with increased ris...