Author byline as per print journal: Rana Musa Ali Al-ali “Malkawi”, MSc; Wesal Salem Al Haqaish, BPharm; Hayel Obeidat, MD Abstract: The regulatory oversight of medicinal products in Jordan is the responsibility of the Jordan Food and Drug Administration (JFDA). In 2015, JFDA adopted biosimilar guidelines, which are similar to those used by the European […]
Author byline as per print journal: Peter J Pitts, BA; Michael S Reilly, Esq Abstract: The World Health Organization should finalize its Biological Qualifier guidance. Distinguishable naming will allow quick and accurate tracing of the manufacturer, should adverse events occur and improve patient safety by reducing confusion and mishaps. This will ensure that developing nations, including […]
Abstract: Representatives from Amgen and Actavis have spoken to GaBI (Generics and Biosimilars Initiative) about biosimilars. Topics covered included the clinical development of biosimilars, the need for further education, how the partnership model between the companies was working, the commercialization of biosimilars and their views on non-proprietary names for biosimilars Biotech giant Amgen and generics […]
Introduction: A survey of the views of European physicians on familiarity of biosimilar medicines has demonstrated the need for distinguishable non-proprietary names to be given to all biologicals. Methods: The Alliance for Safe Biologic Medicines recruited 470 prescribers with clinical experience of biologicals in France, Germany, Italy, Spain and the UK to answer questions relating […]
Abstract: Information about variable immunogenicity arising from formulation differences between competing biosimilars is critical for informed judgments by prescribing physicians. Use of a common INN for biosimilars will obfuscate such differences to the detriment of patients. Submitted: 31 October 2013; Revised: 12 November 2013; Accepted: 13 November 2013; Published online first: 26 November 2013 Immunogenicity […]
Abstract: As a practicing endocrinologist and Chairman of the Alliance for Safe Biologic Medicines, I am writing to commend the World Health Organization for its attention to and upcoming action on the important issue of non-proprietary names for biotech medicines. Submitted: 20 September 2013; Revised: 21 September 2013; Accepted: 21 September 2013; Published online first: […]
Abstract: Nomenclature for biosimilars is a controversial issue. In this issue of GaBI Journal, a paper by Sarshad et al. considers the US FDA’s published system for this and concludes that it will be a positive solution to a global issue. But this may be a premature judgement. Submitted: 1 January 2019; Revised: 3 January […]
