Review Article
A patient-centred paradigm for the biosimilars market
Author(s): James N Class, PhD, Lauren Langis, JD
Page: 17-21
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 »
Biologicals and biosimilars: a review of the science and its implications
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 »
A review of generic medicine pricing in Europe
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… Read More »
Manufacture and regulation of cell, tissue and gene therapy products: global perspectives, challenges and next steps
Abstract: Cell, tissue and gene therapy products (CTGTPs) are therapeutic products intended for use in humans for prophylactic, diagnostic, curative, palliative or diagnostic purposes. Generally, they are breakthrough therapies with… Read More »