The articles in this first issue contain a large volume of useful information on the global development, approval, manufacturing, marketing, and uptake of biosimilars.
The first Original Research by Dr Hye-Na Kang et al. from the World Health Organization (WHO) presents an extensive listing of data on the status of approved similar biotherapeutic products. While, as the authors acknowledge at the end of the manuscript, not all the products listed meet the GaBI’s definition of a true biosimilar, the data demonstrate the gratifying growth in the quantity and impact of such products on the availability and affordability of such products. Increasing availability of biosimilar monoclonal antibodies has been especially noteworthy. However, much remains to be done before the wish that the, ‘adoption of biosimilars will allow affordable health care and greater patient access to important medicinal products’ can become a reality. As noted by the authors, for this to happen, ‘Regulators need to reassess such products to ensure whether they meet the current requirements and to identify the inappropriate labelling of non-innovator and copy-version products (approved when regulatory procedures were not well defined) as biosimilars’.
The second Original Research (the result of work done for a doctoral thesis) by Marzieh Zargaran et al. present data on some potentially, negative, ‘unintended consequences’ of the introduction of follow-on biological products in Iran. While the authors found a ‘downward trend’ in the cost of medications and an increase in product availability, not all six trends in the consumption of locally produced products they observed were positive. There was an increase in consumption of both some ‘domestically produced’ and originator, higher-priced imported products (Pattern 3) as well as some drugs for which there was increased sales of imported medications (Pattern 4) along with decreased sales of domestically produced products. This suggests that the availability of lower-priced products did not always produce the savings expected. The ability to extrapolate these results beyond Iran is limited by Iran’s current economic situation as well as by the definitions used in the data collection. While few other countries are dealing with similar crippling economic sanctions, the concerning trends reported could also occur elsewhere. The definitions used must also be considered when evaluating the data. The authors considered all products manufactured in Iran, whether using imported or only locally produced ingredients, to be ‘domestically produced’. Despite these limitations, the possibility that increased availability of lower-priced biologicals could result in increased rather than decreased overall healthcare costs in other countries should be studied.
The middle section of this issue contains a description of scope of GaBI Journal as well as our Instructions for Authors. Readers are encouraged to read both carefully when submitting manuscripts and comments.
The final Review Article by Adjunct Associate Professor Sia Chong Hock et al. discusses the benefits, opportunities and challenges of the continuous manufacturing (CM) process for both manufacturers and regulators. The authors present a detailed analysis of the challenges that remain to the more wide-spread pharmaceutical industry implementation and regulatory approval of CM processes. Unfortunately, perhaps because the products manufactured to date using CM have been oral solid dosing forms, the authors did not discuss how the use of CM might have impacted the ingredient related shortages of COVID-19 vaccine, monoclonal antibody, corticosteroid, antibiotic and antiviral treatments that have occurred. These authors, as well as all GaBI Journal readers, are encouraged to comment on how the use of CM processes rather than more traditional batch manufacturing might have affected these shortages.
The new year has begun with increasing hope for some easing of the many negative, pandemic-related changes to all our lives that we are experiencing. There is growing appreciation that much of this hope would not be possible without the dedication, sacrifices and efforts of all those people who provide the critically important health, security, services and support to all peoples of this world. It has also never been so obvious how important innovative regulatory and pharmaceutical science, as well as science-based governance are for the people of this world to have a healthier and happier new year.
Professor Philip D Walson, MD
Editor-in-Chief, GaBI Journal
Disclosure of Conflict of Interest Statement is available upon request.
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