This issue of GaBI Journal contains articles dealing with some very practical issues related to the evaluation, describing, and use of generic and biosimilar products. These issues include the uncertainty associated with extrapolating results of studies that used small, non-representative study populations, study sites, or product types. These problems are evident in the evaluation of […]
The current pandemic has greatly amplified the already existing disparities in access to health care. Many countries are facing a lack of access to or funding to pay for the vaccines, medications, protective equipment, and supplies; even oxygen to deal with either COVID-19, wars, famine, and other life-threatening conditions. Patients, families and governments are all […]
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, […]
This issue of the GaBI Journal is being published during one of the most turbulent periods in over a century. A deadly pandemic is raging, the global economy is stressed, and the negative impacts of global weather changes as well as both the number and impact of regional conflicts are all increasing rapidly. While these […]
The Commentary in this issue of the GaBI Journal by Dr Elwyn Griffiths discusses the need for more global harmonization of regulatory approaches to biological medicines. Dr Griffiths refers to the conclusions of the GaBI organized ASEAN (Association of Southeast Asian Nation) conference on this topic. Similar calls have however come from participants in other […]
This issue of the GaBI Journal is being published as the global coronavirus 2 (SARS-CoV-2) pandemic is expanding rapidly in many areas of the world including in the United States of America, South America, Asia, and Africa. While there is no known effective vaccine or cure, preliminary results have suggested that some treatments approved for […]
The current coronavirus pandemic raises some important questions relevant to generic and/or biosimilar products. While still unproven, there are some indications that approved antiviral compounds exist which might be able to decrease coronavirus associated morbidity and mortality. It is also possible that antibody products could be effective. It is not clear however whether/how governments will […]
Patients, their families and providers are facing increasing pressures related to the rapidly expanding global inequality which affects access to all components of a long, healthy, productive life including water, food, shelter, medical care, education, a free press, stable government and freedom from both natural and man-made threats including genocide and war. Attempts to increase […]
The high cost of pharmaceuticals has been gaining increasing attention as a threat to both healthcare systems and patients’ access to care globally. This GaBI issue contains articles focusing on the fact that generics and follow-on biologicals have yet to achieve their potential to mitigate these costs in most if not all countries. In an […]
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 […]
Globalization of the world’s economy has clearly created both major advances and ongoing challenges including in the pharmaceutical industry. Naming of pharmaceuticals might seem to be an uninteresting topic to those outside of the pharmaceutical industry. In fact, as I learned many years ago as a volunteer member of the US Pharmacopeia (USP) Nomenclature Committee, […]
This third issue of GaBI Journal in 2018 contains manuscripts which discuss a number of important, post-marketing, ‘real world’ generic and biosimilar medicinal product issues. In a Commentary, Pitts and Reilly discuss why they believe that unique product names are needed for both generics and biosimilar medicinal products. They discuss the need for consideration of […]
