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

There are many frustrating differences between reality and what is possible in every aspect of life, including politics, economics, science and health. This issue begins with a Commentary by Adjunct Professor Pekka Kurki about the differences between what could be versus what has been done in the European Union (EU) to reduce biological drug costs. The author reviews some explanations for the relatively slow increase in use of biosimilars and concludes that, ‘Biosimilars will probably be adopted sooner in hospitals where the choice of the medicinal product is not an individual prescriber’s choice and where the budget determines the access to medicines’. I agree with the author that, ‘Prescribers and other healthcare professionals, patients, payers, and healthcare administrators are slowly learning the value and nature of biosimilars’. However, in my view this is happening much too slowly. Largely this is because of the effectiveness of methods used by the pharmaceutical industry to slow this process. It is time to introduce much more aggressive attempts to speed this process. Unfortunately, physician and even patient choices may have to be restricted if patient access to reasonably priced health care is to be preserved. This will require care to avoid unintended negative consequences such as replacing high costs with less effective, lower quality, or more toxic alternatives as illustrated by the recent closure of a biosimilar production facility (see the Pharma News section of this issue).

Production of high quality generics and biosimilars requires high quality pharmaceutical ingredients. Unfortunately, not all ingredient producers/suppliers face the same quality or regulatory control standards. The magnitude of the problem is illustrated in an Original Research by Mr Maki Matsuhama and Dr Ryosuke Kuribayashi that analyses the thousands of Drug Master Files for active pharmaceutical ingredients registered in Japan; almost two thirds of which were found to come from foreign suppliers in 46 countries on seven continents. It is clear that such diversity has the potential to introduce unwanted variability in end product quality and performance. Concerns about global pharmaceutical variability is one concern physicians may point to when justifying their reluctance to prescribe biosimilars.

In a ‘descriptive’ Review Article O’Brien et al. present a telling description of the introduction of an infliximab biosimilar into an inflammatory bowel disease care pathway in a large acute Irish teaching hospital. Despite being overwhelmingly supported by the evidence, there was still reluctance to accept switching of patients from the originator to a biosimilar. Initially only new patients were started on the biosimilar but gradually even established patients were switched. The authors use this example to support their conclusion that, ‘a distinct and individualized approach for biosimilar medicine implementation is required’. The authors also express the hope that publication of a national biosimilar medicines policy will improve clinical acceptance of biosimilar medicines. To me the story suggests that education and publication/review of additional clinical research will need to be supplemented or even replaced by more aggressive methods to overcome clinicians’ skepticism that is not evidence based.

Religion is a less commonly discussed factor that can influence therapeutics. Better known examples include refusal to use blood products (Jehovah’s Witnesses), pork containing products (Muslims and Jews), and contraceptives or abortifacients (Catholics, fundamentalist Christians and others). In a Review Article Alhomaidan et al. discuss ‘the impact of religion on human embryonic stem cell regulations’. As would be expected based on the democratic principle of separation of church and state, these non-theocratic countries have widely different human embryonic stem cell regulations that are not always predicted based on their religious teachings.

In a Regulatory article, Ms Johanna Andrea García Cortes and Mr Francisco Javier Sierra Esteban outline the legislation being developed in Colombia to approve biological/biosimilar products for entry onto the Colombian market. They also present the three separate regulatory approaches (complete dossier, comparability, and abbreviated comparability) that have been developed to approve biological therapeutic products in Colombia. These pathways were described at the GaBI organized INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) Second Colombian Scientific Meeting on Quality Assessment of Biosimilars/Similar Biotherapeutic Products held in August 2017. While it is important to document different regulatory approaches and it is clear that politics (including regulations) are clearly ‘local’, one cannot avoid wondering whether a more globally or even regionally harmonized approach would not be possible and more efficient. The potential advantage of such harmonization is perhaps best illustrated by the Editor’s comments that follow the Pharma News section of this issue which cautions, ‘that “similar biologics” approved in India, “non-originator biologicals” approved in Russia or South Africa and “similar biotherapeutic products” approved in Latin America might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the EU’.

A Special Report presents the 2017 updated list of patent expiry dates for biologicals. This list illustrates the potential of biosimilars to decrease healthcare costs and increase patients’ access to these important treatments. Unfortunately, this potential is still seldom realized; despite a large and rapidly growing body of evidence of similar efficacy and tolerability as illustrated in the last two sections; each prepared by our GaBI Journal editorial staff.

The Pharma News summarizes a number of important published reports on a wide range of relevant developments in biosimilars including articles covering methods used to delay their introduction, citizens’ petitions, naming, substitution/interchangeability, US Food and Drug Administration guidance, as well as results of clinical trials of follow-on adalimumab, bevacizumab, filgrastim, infliximab, pegfilgrastim, ranibizumab, rituximab, tocilizumab and trastuzumab products.

The final Abstracted Scientific Content summarizes two articles that compared US and European generic drug markets and discuss barriers to generics policy reform. The articles cover the history of generics substitution, regulation of bioequivalence, and the chances for reform.

The generics and biosimilars story continues to be a work in progress with far more potential that actual successes in providing high quality follow-on products at much lower costs to more and more patients worldwide.

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

Disclosure of Conflict of Interest Statement is available upon request.

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