Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, The Netherlands.
Acta Clin Belg. 2021 Dec;76(6):441-452. doi: 10.1080/17843286.2020.1761690. Epub 2020 May 13.
More than ten years after the first biosimilars were authorized for use in the European Union, Belgium still experiences limited competition from biosimilars, as exemplified by low market shares. Achieving high biosimilar market shares is not necessarily a goal in itself, as cost savings are also realized by mandatory price reductions on originator medicines in Belgium. However, we believe that biosimilars play a role in ensuring the long-term sustainability of the off-patent biologicals market. It is therefore crucial to list what has been done and what is needed to support the Belgian government in establishing a policy framework for a competitive off-patent biologicals market. We provide a comprehensive overview of the Belgian biosimilar market, including existing hurdles for biosimilar use in Belgium. Based on these hurdles and supplemented with learnings from other European countries, we propose practical recommendations that can be implemented to overcome them. Several Belgian stakeholders had the opportunity to comment on these recommendations. Specifically, we suggest to evolve towards a long-term consistent, integrated policy framework via i) the creation of a proactive and transparent climate supporting a level playing field for both biosimilar and reference product, including public dissemination of how savings at the level of the Belgian healthcare system are used, ii) investment in educational activities, including raising awareness of societal responsibility, iii) enforcement of the practical implementation of public procurement law, and iv) the development of incentives for physicians, who are key stakeholders in the Belgian off-patent biologicals market.
在欧盟首次批准生物类似药使用十多年后，比利时仍然面临生物类似药竞争有限的问题，市场份额低就是明证。在比利时，通过对原研药进行强制性降价也能实现成本节约，因此实现高生物类似药市场份额本身不一定是目标。然而，我们认为生物类似药在确保专利过期生物制品市场的长期可持续性方面发挥着作用。因此，至关重要的是要列出已经采取的措施和需要采取的措施，以支持比利时政府为竞争激烈的专利过期生物制品市场建立政策框架。我们提供了比利时生物类似药市场的全面概述，包括比利时生物类似药使用的现有障碍。基于这些障碍，并结合其他欧洲国家的经验教训，我们提出了切实可行的建议，可以实施这些建议来克服这些障碍。几位比利时利益相关者有机会对这些建议发表意见。具体而言，我们建议通过以下方式逐步建立长期一致、综合的政策框架：i）营造一个积极主动、透明的环境，为生物类似药和参比制剂创造公平竞争的环境，包括公开传播比利时医疗保健系统层面的节约如何使用；ii）投资教育活动，包括提高对社会责任的认识；iii）执行公共采购法的实际实施情况；iv）为医生制定激励措施，因为他们是比利时专利过期生物制品市场的关键利益相关者。
