Latest features in GaBI Journal, 2023, Issue 3

Generics and Biosimilars Initiative Journal (GaBI Journal). 2023;12(3):75
DOI: 10.5639/gabij.2023.1203.012

Published in: Volume 12 / Year 2023 / Issue 3
Category: Editor's Letter
Page: 75
Author(s):
Visits: 750 total, 5 today

The articles in this issue of the GaBI ­Journal highlight two important issues that must be considered when reading scientific publications. The first two articles illustrate the rapidly expanding influence of non-US, non-European economies on the global pharmaceutical industry. The second two articles illustrate the need to carefully evaluate the role of any potential author bias on an article’s content or conclusions.

The first Review Article by Alhomaidan et al. presents extensive observational data collected by the Saudi Food and Drug Authority (SFDA) of their pharmaceutical products approval and regulation procedures over the past 10 years. The authors describe the most prevalent product review gaps and good manufacturing practices (GMP) inspection deficiencies noted. They summarize the evolution of laws and standards that impact drug regulation, examine the use of new approval programmes and standards, and delineate the changes in the number of drugs approved from 2011 to 2021. The SFDA’s long-term objective is to, ‘establish itself as a global hub of regulatory excellence and hasten patient access to medications’. Saudi Arabia as well as some other countries in the Middle East and North Africa (MENA) region are already playing an increasingly important, outsized role in other aspects of the global economy. The influence of the MENA region on the global pharmaceutical industry is likely to only increase.

The second Review Article by Ka-Liong Tan et al. discusses the incorporation of a Halal Management System (HMS) by the rapidly growing halal pharmaceutical industry. The authors outline aspects of the HMS in the development and production of halal pharmaceuticals, explain the needs and requirements of an HMS, identify the challenges faced in implementation and establishing standardized certification, traceability, and effective recall mechanisms. The article should be of interest to any industry or company involved in the development, promotion, sale, or regulation of pharmaceutical products to the almost two billion Muslims in the world as well as to members of non-Muslim faiths that also follow basic halal dietary practices.

The Meeting Report by Reilly et al. presents in detail a summary of an online seminar sponsored by the Alliance for Safe Biologic Medicines (of which Mr Reilly is the Executive Director) and organized by GaBI staff. The meeting focused on the potential of the Inflation Reduction Act (IRA) to decrease innovation and new drug development as well as decrease patient access to some medications resulting from the price negotiations required by the act for a limited number of medications. Of note, the discussion focused solely on European and US effects of price controls. Much of the world’s population was simply not mentioned. The potential for the cost savings generated by the act to increase overall patient access to medications was also largely ignored. Finally, while no specific conflicts of interest were declared, there are numerous potential conflicts of interest raised by the relationships between the speakers and the pharmaceutical industry and other commercial interests that are likely to be financially adversely affected by the IRA. It is clearly important to consider all potential unintended consequences of legislation. I personally however wish that the meeting had included at least someone involved in the administration’s calculations of the potential positive economic and patient access implications of the act. It would also have been useful to present at least some data on non-pharmaceutical industry-based drug development methods such as those funded by governments and non-profit organizations, e.g. Gates Foundation, NIH, universities, WHO, governments.

The final article in this issue by Dr Richard L Easton discusses various methods available to assess the higher order structure and aggregation of antibody drug conjugates, an interesting and promising class of biological methods. As an employee of a supplier of these methods to industry, the author’s potential conflicts of interest are clear. The presentation is; however, straightforward and (at least to me) unbiased. The acceptance of these methods by regulators will be critical in how they are incorporated into the regulatory process.

I realize it is difficult to be motivated to submit comments when faced with a world in which access to shelter, food and water is not guaranteed to an increasing number of the world’s population. Nevertheless, readers are encouraged to submit comments on these or any other topics.

Professor Philip D Walson, MD
Editor-in-Chief, GaBIJournal

Disclosure of Conflict of Interest Statement is available upon request.

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