Author(s): James N Class, PhD, Lauren Langis, JD
Abstract: The advent of similar biological medicinal products or ‘biosimilars’ in Europe in the 2000s has led to development of a global biosimilars market and regulatory frameworks designed specifically for… Read More »
Abstract: Biopharmaceuticals are medicines whose active drug substance is made by living cells. Copies of these drugs, called biosimilars, are not identical to their reference drug and therefore specific regulatory… Read More »
Author(s): Professor Steven Simoens, MSc, PhD
Introduction: Switching from originator products to generic equivalents is a key method used by governments to reduce costs and keep their healthcare systems sustainable. The aim of this article is to review… Read More »
Does L-Thyroxine meet the criteria of a narrow therapeutic index drug (NTID) according to Bioequivalence-guideline of the European Medicines Agency?
Aim: This review discusses pros and cons of whether L-Thyroxine should be regarded as a narrow therapeutic Index drug (NTID). Methodology: A search in PubMed was performed in March/April 2014.… Read More »
Abstract Introduction: The first biosimilar was launched on the European market in 2006 and since then, the US market has been anticipating their arrival and the potential cost savings that biosimilars… Read More »