The workshop included a session on ‘Potential tools to optimize the benefits of biosimilars from the societal perspective’. The session highlighted that the aim of pharmaceutical policies was not just to reduce healthcare expenditure, but also to improve the health of society.

In his presentation, Zoltán Kaló, Professor of Health Economics at the Center for Health Technology Assessment, Semmelweis University and the Syreon Research Institute, highlighted a case study on breast cancer. The study showed that European uptake of human epidermal growth factor receptor 2 positive (HER2+) drugs indicates access restrictions in lower income countries and that European data on breast cancer five-year net survival indicates a greater unmet need for biologicals in lower income countries. This, according to Professor Kaló, proves that biosimilars are a game changer for both healthcare sustainability and increased patient access.

However, Professor Kaló also points out that there remains challenges to biosimilar uptake in certain European countries. Current challenges include fear of immunogenicity, acceptance of international scientific evidence and attempts by originators for product differentiation.

Fear of immunogenicity
Professor Kaló questions whether this is a ‘real concern or just hype based on scientific literature?’ According to his research there exist 41 non-empirical papers stating a hypothetical risk without any empirical justification, e.g. clinical trial data. Whereas, there are 12 empirical papers indicated that switching to biosimilars is not accompanied by increased risk of immunogenicity, significant adverse events, loss of efficacy according to current clinical evidence.

Professor Kaló concludes that prevention of switching to biosimilars in fear of these reasons seems to be disproportional. He adds that the short-term consequences could be that it ‘may harm improved patient access’. While long-term consequences are that it ‘may harm long term sustainability of health care (assuming increasing share of expenditure on biologicals).

Finally, he points out that the European pharmacovigilance system is capable of detecting any signals related to immunogenicity.

Acceptance of international scientific evidence
Professor Kaló asks ‘why policy makers and/or regulators in some countries still question what has been answered in other countries?’ In his opinion ‘there is no need to repeat for regulators what has already been confirmed by others, e.g. in Denmark or Norway’. This he says ‘is especially true for lower [income] countries. He adds that ‘it is not realistic for a global industry that each country has to re-create its own pool of supportive evidence from scratch’.

He also points to the fact that ‘mutualisation of evidence generation is essential in the European Union. European Public Assessment Reports (EPARs) and EPAR public summaries are a fundamental resource of information’.

Attempts by originators for product differentiation
Professor Kaló cites the example of the ‘hype’ behind subcutaneous trastuzumab. He attempts to evaluate the benefits and their transferability based on scientific literature. According to his research, there are 42 articles included in the review to compare intravenous trastuzumab (IVT) and subcutaneous trastuzumab (SCT).

He found that:
• The similarity of adverse event profiles of SCT and IVT could not be validated, as statistical test results were rarely reported.
• Potential time savings for patients due to subcutaneous administration was not validated especially in Eastern European settings, where patient’s waiting time for treatment administration is fairly long.
• Standard patient reported outcome instruments were rarely used to confirm the preference of patients/healthcare professionals to SCT over IVT.
• Feasibility of self/home administration of SCT, especially in case of concomitant intravenous chemotherapies, was not considered.
• Cost comparisons did not consider 1) either price erosion of IVT; or 2) the incremental cost of potential differences in adverse events.

Professor Kaló concluded that to optimize the benefits of biosimilars for society national targets are needed, biosimilars should be first-line therapies for treatment naïve patients, and for stable patients switching to lower-priced alternative biosimilars should be carried out under medical supervision.

Related articles
Proposed policies to maximize societal benefit of biosimilars

EC workshop on biosimilars focusses on sustainability

Reference
1. European Commission Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs. Multi-stakeholder workshop on biosimilar medicinal products; 30 October 2019; Brussels, Belgium.

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