Commentary on the recommendations of the European Society for Organ Transplantation Advisory Committee on generic substitution of immunosuppressive drugs
Journal Title: Generics and Biosimilars Initiative Journal - Year 2013, Vol 2, Issue 3
Abstract
In 2010, the Council of the European Society for Organ Transplantation formed an Advisory Committee to formulate recommendations on the use of generic drugs in solid organ transplant recipients. The initiative was taken as a result of concerns regarding generic substitution of immunosuppressive drugs. The recommendations were published in Transplant International, and this paper is a short summary of its contents.
Authors and Affiliations
Teun van Gelder
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...
Statistical considerations for the development of biosimilar products
As the patents of a growing number of biological medicines have already expired or are due to expire, it has led to an increased interest from both the biopharmaceutical industry and the regulatory agencies in the develo...
A patient-centred paradigm for the biosimilars market
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 approval of biosimilar...
Latest features in GaBI Journal, 2012, issue 3-4
This issue of the GaBI Journal uses a number of article formats to cover a range of issues related to generics and biosimilars.
Assuring patient-centred care: engaging patients with rheumatoid arthritis in disease monitoring and pharmacovigilance
With the advent of complex therapies in the form of biologicals, emerging biosimilars and non-biological complex drugs, monitoring for treatment related benefit and the potential for adverse effects is as critical as mon...