GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 5 / Year 2016 / Issue 1
Regulatory
The EU is ready for non-biological complex medicinal products
Author(s): Falk Ehmann, MD, PhD, MSc, Ruben Pita, PharmD, LLM
Page: 30-5Abstract: This paper describes the existing European Union legislation and scientific guidance to adequately assess the quality, safety and efficacy, as well as the lifecycle management, of the group of non-biological complex drug (NBCD) products, including nanomedicines such as liposomes, polymeric micelles, glatiramoids and iron-carbohydrate complexes. Submitted: 15 March 2016; Revised: 1 April 2016; Accepted: […]
Pricing of biosimilars in Saudi Arabia
Author(s): Ali M Alhomaidan, PhD, Fahad S Alnutaifi, MHEcon, MPH, Ibrahim A Aljuffali, MSc,PhD, Nasseruddeen A AL-Howaimel, MSc
Page: 27-9Author byline as per print journal: Ali M Alhomaidan, PhD; Ibrahim A Aljuffali, MSc, PhD; Fahad S Alnutaifi, MHEcon, MPH; Nasseruddeen A AL-Howaimel, MSc Abstract: Innovation in the pharmaceutical industry is expensive and risk must be rewarded. Some novel pharmaceuticals may be worth their high prices. Yet, high prices may hinder accessibility to novel products. […]
