Editor’s introduction to the initial issue of the ninth volume of GaBI Journal

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 deal with regulatory approval or access to such products or what/whether/where reimbursement will be available for their use. These questions may soon need to be answered, especially if the only effective treatments are on-patent products unapproved for use to treat coronavirus. It is important that public health officials develop plans for such a possibility as soon as possible since the current pandemic is neither the first nor the last serious epidemic which will occur. Planning should include careful consideration of what the best practices have been for making generic and biosimilar products available globally. The current issue of the GaBI Journal contains manuscripts that cover a wide range of issues relevant to such planning.

The first Original Research by authors from Amgen presents some of the kind of information which is needed but not always available to those front-line personnel tasked with the preparation and distribution of biosimilar products. Manufacturers, regulators and non-governmental groups, e.g. the World Health Organization (WHO) and the US Pharmacopeia, should all consider how best to proactively promote the collection and distribution of such information for all biological products before an emergency occurs since, as the authors point out, ‘Once drug infusions are prepared, the way that they are stored and transported might affect whether they work’. Readers who have access to any similar but unpublished data are encouraged to submit it to the GaBI Journal for publication.

The pricing of pharmaceuticals is critical to patient access in every country, in usual as well as emergency situations. It is useful for stakeholders to be aware of the wide diversity of both the approaches used and their success. The second Original Research by Dr Alian A Alrasheedy describes the pharmaceutical pricing policy being used in Saudi Arabia. The author claims these policies have, ‘resulted in significant price differences among medicines, including medicines of the same molecule’. Those responsible for pricing need to understand which approaches work for which types of product if they are going to be able to deal with pricing/reimbursement issues which occur before as well as during public health emergencies. It is likely to be some time before the full impact of inadequately planning for such an emergency becomes clear, but the slow roll-out of coronavirus testing in the US is at least in part one such result.

While not everyone would agree that the rising incidence of cancer is also a pandemic, it is clear that the number of patients with cancer, the number of different treatments available, as well as the costs of treatment are all increasing rapidly throughout the world. In the Perspective paper, Dr Paul Malherbe examines how non-governmental organizations (NGOs) might help governments, ‘decide which registration applications to prioritize’. The magnitude of the problem is illustrated by the fact that, ‘In South Africa, median approval times for marketing authorization applications approved in 2015, 2016 and 2017 were 1,218, 921 and 609 calendar days, respectively, for “fast track&8221 applications’. The recent delay in getting coronavirus testing materials into the hands of US health departments demonstrate that delays in making important therapeutic products available are unfortunately not limited to South Africa.

Patient access to reasonably priced generic and biosimilar products requires that such products are registered, manufactured, prescribed and accepted by patients for both routine and emergency use. Multiple approaches have been used, with variable success, to support the use of biosimilar products. In the Legal paper, Ms Maria Fabiana Jorge summarizes why she is concerned that the recent United States-Mexico-Canada Agreement (USMCA) will have a major negative impact on both patients’ access to generic medications and the sustainability of the generics industry. She summarizes why she believes that: a) ‘Trade agreements … have become a tool for some interest groups to tilt the laws and regulations in their favour, at the expense of consumers’; and, b) ‘the USMCA includes a number of problematic provisions that will delay access to medicines not just for consumers in Canada and Mexico, but also in the US. Furthermore, it will negatively impact the US generics and biosimilars industry in the three markets’. The author works for the generics industry, but has had experience negotiating trade agreements, including the New Trade Policy or May 10th Agreement between the US and Colombia, Panama and Peru. She argues that in contrast to USMCA this agreement, ‘set a precedent for striking a better balance to promote both innovation and access’. I have absolutely no experience with any trade agreements, but I found her observations worthy of serious consideration and follow-up. Interested readers might also want to review recent executive branch actions that have weakened the US Consumer Financial Protection Bureau [1].

As pointed out in the Opinion by Dr GR Soni, India is an example of a country where policies based on the European experience may not be successful. Biological products which are found to have any, ‘major deviation(s) from science-based principles in the manufacturing of a recombinant DNA-derived therapeutic biological product’ are classified in India as a ‘non-innovator’ biological or NIBP. Such products can have major differences from originator products they were designed to replace. The author contends that the reasons that some NIBPs continue to be developed and then inappropriately approved and used include ‘brief and poorly implemented guidelines on biologicals, a lack of expertise on biosimilars amongst drug regulatory committees, lack of coordination among government departments working on biosimilars, poor quality accreditation in testing laboratories, and a lack of patent protection for innovator drugs’. As a solution to this situation, the author proposes that, ‘There is an urgent need to identify deficiencies in the ministries responsible for biosimilars in India, which could be through a scientific audit. Compliance with such an audit could strengthen the Indian regulatory system and thus increase the provision of affordable, high quality biosimilars’. I do not have enough personal experience with the Indian healthcare system to judge these claims. However, I suspect that both the magnitude of the problems associated with NIBPs and the rationale for applying European biosimilar processes depend on a cost-benefit analysis of the two, alternative approaches. It is not clear, to me at least, whether patients in India would be best served by having only biosimilar products that meet more stringent European guidelines available. This question is likely to be faced by many other countries, including those with even more limited resources and those dealing with international sanctions or public health emergencies. Our readers are encouraged to submit their comments on this or related questions.

Pharma News provided a summary of follow-on biological product developments which occurred in 2019. This listing was compiled from material published in both this GaBI Journal and GaBI Online (www.gabionline.net). Regulatory approvals are listed by country/manufacturer for biosimilar versions of adalimumab, bevacizumab, darbepoetin alfa/epoetin alfa, dornase alfa, eculizumab, etanercept filgrastim/pegfilgrastim, heparin, infliximab, insulin glargine, rituximab, teriparatide and trastuzumab. Clinical studies of biosimilars which were published in 2019 are briefly described as are non-clinical research and reports concerning the biosimilar market in Europe and the US as well as prescribing practices, switching, education, new regulatory guidance (US and internationally), as well as some important new collaborations, agreements and investments. As noted by GaBI Journal’s editor, the products mentioned (including those from China, India and Russia) do not all meet European Union requirements for approval of biosimilars. While the future of biosimilars is going to be challenged by the currently decreasing number of biologicals with expiring patents; the article nevertheless illustrates the large number and wide geographical distribution of encouraging activities which occurred in 2019.

Professor Philip D Walson, MD
Editor-in-Chief, GaBI Journal

1. Herron J. Consumer protection wanes under Trump, reports find. USA Today. 2019 Mar 13.

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