Change is inevitable but often resisted, including or even especially in medicine. Hand washing is still neglected 170 years after Semmelweis’ work, misuse of antibiotics persists 72 years after Fleming warned about it, and use of generics and biosimilars remains suboptimal. This final 2017 issue of the GaBI Journal deals with many of the barriers […]
It is clear that greater use of generics and biosimilars could greatly decrease healthcare costs and thereby increase availability of important medicines. It is equally clear that these potential savings are seldom achieved. The disconnect between what is possible and what is being achieved is related to a lack of trust on behalf of patients, […]
The use both generics and biosimilars offers the potential to increase availability of medicines through decreases in cost that should occur when an expensive product (drug) loses patent protection and lower cost alternatives are marketed in countries with a ‘free-market’ economy. As the manuscripts in this issue of GaBI Journal emphasize, it is clear however […]
This first issue of 2017 includes a range of manuscripts of interest to readers. A Letter to the Editor from Professor Mohamed Izham Mohamed Ibrahim and Nada Moustafa Abdel Rida proposes steps that governments and international organizations have taken or need to do, especially with respect to pricing of pharmaceuticals, to make ‘Essential Medicines’ more […]
This fourth and final GaBI Journal issue of 2016 begins with the paper by Adjunct Professor Pekka Kurki about ‘applying ancient principles in a modern society’ in which he discusses a perspective recently published in our journal from Annese et al. that presented the skeptical views expressed by Italian gastroenterologists concerning extrapolation of indications for […]
The informed, appropriate use of follow-on pharmacological agents can provide significant cost savings for patients and payers. These savings can then be used by governments and patients to increase access to health care. However, the actual savings realized depend on a complex series of factors including how ‘similar’ the products actually are to the innovator […]
This second issue of 2016 includes manuscripts that cover a number of important issues of interest to GaBI Journal including methods used to assess bioequivalence and decide on interchangeability, patient and advocacy group opinions concerning the use of follow-on products, batch-to-batch consistency in monoclonal antibody production, and the causes and potential ways to deal with the […]
This issue begins with a Letter to the Editor by Professor Fabio V Teixeira from the Brazilian Inflammatory Bowel Disease (IBD) Society that deals basically with the issue of extrapolation of indications. The letter states that ‘vigilance remains essential’ for the use of this agent in IBD patients. Professor Teixeira’s letter is in response to […]
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: […]
