This last issue of 2015 starts with a Commentary by Drs Christoph Baumgärtel and Brian Godman concerning the approval of generic versions of narrow therapeutic margin products; including immunosuppressant drugs. The authors explain why they find concerns that have been raised by some clinicians concerning the bioavailability margins needed for approval of narrow therapeutic drugs […]
This issue of the journal contains a number of manuscripts that discuss proposals to simplify the evaluation of, and therefore decrease the cost of developing, follow-on biological products. These controversial proposals include extrapolation of indications, abbreviated approval processes in resource-poor countries, biological/biosimilar nomenclature, and patent litigation strategies. Dr Frits Lekkerkerker, reviews the paper by Gerrard […]
This entire issue of the GaBI Journal could be titled ‘World News’ since it contains manuscripts describing global generics and biosimilar activities. The Commentary by Leng et al. describes regulatory events in South Africa that led to claims of delay in marketing approval of generic drug products. The authors discuss the relationship between regulatory policies […]
This first 2015 GaBI Journal issue (fourth volume of the journal) is being published soon after the first US biosimilar approval and it contains a number of articles that illustrate how the development, marketing and acceptance of biosimilars differ globally including in North and South America and the Persian Gulf States. An Editorial entitled Biosimilars: […]
The interest in the development, regulatory approval, use, and post-marketing surveillance of generic and biosimilar pharmaceutical products continues to increase; as illustrated by the tremendous number of views (over 1,028,324 since 2012) of articles published in the GaBI Journal. I expect that this interest will continue to increase after publication of this fourth and final […]
This issue of the GaBI Journal begins with editorial comments from our Deputy Editor-in-Chief Dr Robin Thorpe concerning the Review Article by Azevedo et al. covering biosimilar regulations and their implementation in some Latin American countries. Three Original Research papers describe real life clinical examples relating to the use and evaluation of follow-on products respectively; […]
As mentioned previously, non-biological complex drugs (NBCDs) continue to raise important regulatory and practice issues. This issue of the GaBI Journal contains a number of manuscripts dealing with these products and begins with an update on NCBDs (nanosimilars) developments by Professor Gerrit Borchard. This is followed by a manuscript discussing the use of size and […]
This issue of the GaBI Journal begins with editorial comments from our Deputy Editor-in-Chief Dr Robin Thorpe concerning the Review Article by Azevedo et al. covering biosimilar regulations and their implementation in some Latin American countries. Three Original Research papers describe real life clinical examples relating to the use and evaluation of follow-on products respectively; […]
This issue marks the forth and final issue of the second year’s edition of the GaBI Journal. The journal has grown rapidly through the combined efforts of the publisher and her staff, all of the members of the executive editorial board and the international editorial advisory board, our contributors, advertisers and readers for which I […]
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 position from the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA). Dr Casadei questions how much of a ‘step forward’ as well as […]
The first of two Letters to the Editor is from Ms Gaspani and Ms Milani expressing their concerns about the lack of clear regulatory guidelines for approval of liposomal generic formulations. Liposomal products are only one and perhaps some of the best-characterized example of non-biological complex drugs (NBCDs). NBCDs while not having a biological source […]
We start off the second year of GaBI Journal with articles covering a wide range of issues. In Letters to the Editor, Dr Christian K Schneider discusses and expands on a previously published article by a bioethicist [1] on the ethics of biosimilars. Dr Schneider applauds the inclusion of ethicists in the debates concerning biosimilars […]
