This issue contains important information and manuscripts, but the small number of original papers illustrates the challenge the GaBI Journal (as well as many other legitimate journals) is having attracting quality work. This challenge may at least in part be the result of the rapid growth of medical journals. There are now tens of thousands of medical journals competing for manuscripts; not all of which are legitimate. Authors (as well as reviewers) are also being subjected to aggressive ‘marketing’ by many ‘predatory’ journals. A recent Google search for, ‘predatory medical journals’ had over 4,300,000 hits concerning this growing problem. Interested readers are directed to some selected examples of articles discussing this problem by Sharma H, Verma S. Predatory journals: the rise of worthless biomedical science. J Postgrad Med. 2018;64(4):226-31); Laccourreye O, et al. ‘Predatory’ journals threatening the scientific medical press. Eur Ann Otorhinolaryngology Head Neck Dis. 2018;135(1):37-9; and Bowman MA, et al. Beware of predatory journals: a caution from editors of three family medicine journals. J Am Board Fam Med. 2018;31:671-6. Regardless of the cause, I want to personally appeal to readers to suggest how GaBI Journal might increase its appeal to authors who submit their relevant manuscripts for publication.
Confounding the challenge is the multi-disciplinary nature of the use of generic and biosimilar products as illustrated by the first Legal manuscript in this issue entitled ‘Biosimilars: considerations in light of the Italian legal framework’ by Professor Enrico Adriano Raffaelli and Fausto Massimino. These authors review in depth Italy’s 2017 Budget Law. This law was passed after ‘a heated debate on legal doctrine and jurisprudence about biosimilars’.
GaBI Journal created a separate Legal Section to be able to encourage submissions by legal scholars. We hope that our non-lawyer readers will not be discouraged by its non-medical format, e.g. the use of footnotes rather than references. It contains important, interesting, practical information on how this Italian law was developed to deal with all the issues faced by stakeholders including automatic substitutability between biological and biosimilar products, the purchasing of such medicines, and physician’s freedom of prescription in a way that was designed to encourage widespread adoption and increase availability of biosimilars. The authors discuss the interplay between free market forces and the realities of societal responsibilities/government budgets. The law sets out some principles that define the regulatory framework created by this law. These principles include accepting that the physician’s freedom of prescription is a priority; but recognizing that so is patients’ safety and protection. The law makes an important distinction between ‘Simple versus Complex’ biologicals and covers diverse topics including regulation, pricing, naming, interchangeability, automatic substitution, switching, pharmacovigilance, and even pricing/procurement. The authors also discuss the interactions between central EU versus Member State specific control. A particularly pertinent part of the manuscript deals with the role of the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA), as ‘the ultimate guarantor of fairness, scientific accuracy and objectivity of the information provided’ in marketing materials used to promote products. I personally suggest readers do not avoid reading all of the footnotes as these contain descriptions of a number of very important legal precedents. Finally, I would welcome comments from our readers on the article, the law itself, or the Legal Section itself.
The second paper entitled ‘Patent expiry dates for biologicals: 2018 update’ provides an updated overview of the current between country differences in the impact of biological patent loss and a listing of products with their EU and US patent expiration dates.
The Pharma News discusses the major biosimilar developments in a number of countries which occurred during 2018, a listing of important clinical studies reported for some biosimilar products, as well as some new biosimilar regulations, guidance, and position statements on biosimilars. Biosimilars developments concerning naming, interchangeability, substitution, switching, clinical trials (by product), as well as studies concerning cost savings and barriers to uptake of biosimilars are briefly reviewed. Some important new collaborations, agreements and investment in biosimilars are listed as are some notable discontinuations of biosimilars development. Readers should note the important Editor’s comment at the end of this article that some of the news items concerning ‘similar biologics’ approved in India, ‘copy biologicals’ approved in China and ‘similar biotherapeutic products’ approved in Latin America refer to products which are not necessarily ‘biosimilars’ by EU/US standards.
The final Abstracted Scientific Content entitled ‘Regulatory requirements for the acceptance of foreign comparator products in the participants of the International Generic Drug Regulators Programme’ abstracted by Dr Alfredo García Arieta, Clare Rodrigues and Christopher Crane from a published paper and internally peer reviewed. The paper discusses problems involved in the selecting/using of biosimilar comparators.
Professor Philip D Walson, MD
Editor-in-Chief, GaBI Journal
Disclosure of Conflict of Interest Statement is available upon request.
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