Review Article

Biologicals and biosimilars: a review of the science and its implications

Published in: Volume 1 / Year 2012 / Issue 1
Author(s):
Page: 13-6

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

Published in: Volume 1 / Year 2012 / Issue 1
Author(s):
Page: 08-12

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?

Author(s):

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 »

Roundtable on registries: practical considerations for registries – making them work, London, UK, 26 January 2017

Introduction: A registry is “an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular… Read More »

A survey of Australian prescribers’ views on the naming and labelling of biologicals

Author(s): ,

Introduction: As the number of biosimilar approvals in Australia increases, it will be important to establish a fast track regulatory framework to bring high quality, safe and efficacious biosimilars to… Read More »

Real world data about biosimilars: results from an Italian distributed network

Author(s): , , ,

Abstract: In recent years, drug expenditures of National Health Systems have grown significantly due to the marketing of high-cost molecules, including biological drugs. Biosimilars contain the active substance of an… Read More »

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