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Journal Title: Generics and Biosimilars Initiative Journal - Year 2012, Vol 1, Issue 2
Abstract
A patient-centred paradigm for the biosimilars market This article provides important insights into the use and application of complex biologicals, particularly biosimilars, in health delivery systems. One aspect of care that has been traditionally ignored by providers as well as the private sector is the patient experience. Although much has been said about ‘patient-centeredness’, what this means generally is lip service to minor changes and form, rather than a substantive focus on what, how, and when patients receive ‘treatment’, not just a drug.
PMDA update: the current situation and future directions
The Pharmaceuticals and Medical Devices Agency (PMDA) is a Japanese drug regulatory agency, sharing responsibilities with the Ministry of Health, Labour and Welfare. Its mission is to protect the public health by assurin...
Latest features in GaBI Journal, 2013, Issue 3
The GaBI Journal again contains manuscripts covering a wide range of pertinent topics. In an Editorial, Dr Gianluigi Casadei reviews Italy’s final position paper on biosimilars including the new price and reimbursement p...
Challenges to generic medicines utilization in Yemeni healthcare system
Generic medicines are promoted in many countries as an essential part of the healthcare system. However, in Yemen, there are many challenges to the utilisation of generic medicines. Currently, there is no national level...
Generic and therapeutic orphans
This commentary discusses the need to develop methods to ensure the availability of non-profitable, off-patent medicines to children and other populations. The history and some of the shortcomings of legislative attempts...
Biosimilarity in Latin America
The introduction of new legislation in Latin America for the approval of biosimilar products follows implementation of EU legislation in 2005 for biosimilars approval. The establishment of regulatory processes for these...