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Biosimilars in Belgium: increasing competition Posted 03/07/2020

Competition following the entry of biosimilars is still limited in Belgium, which is mirrored in low biosimilar market shares. Although (short-term) cost savings are realized by the implementation of mandatory price reductions on originator medicines (and obtaining high biosimilar market shares should thus not be a goal in itself), biosimilars can play a key role in ensuring the long-term sustainability of the Belgian off-patent biologicals market.

In a paper by Moorkens et al., the authors provide an overview of the biosimilar landscape in Belgium with regards to biosimilar uptake, relevant policy measures and hurdles for the use of biosimilars [1]. Based on the identified country-specific hurdles, and supplemented with learnings from other European countries, the authors propose a series of avenues and recommendations to increase competition in the off-patent biologicals market in Belgium.

In 2019, biosimilar market shares in Belgium varied from 2% for trastuzumab biosimilars to 46% for infliximab biosimilars, with most biosimilar market shares still below 20%. A number of actions to stimulate competition from biosimilars have been implemented starting from 2016, in the form of ad hoc policy measures and initiatives, but seem to have only a minimal effect. An important structural barrier for the use of biosimilars is the absence of tangible benefits and incentives for several stakeholders. Additional cost savings from the use of biosimilars are, in the short term, limited for the reimbursement agency. Physicians go through the burden of change, but do not benefit from associated cost savings. This is also the case for pharmacists and patients. Only hospitals could financially gain from competition when tendering, but in practice the opening of tenders is delayed due to several arguments discussed by the authors.

To overcome existing hurdles and increase competition in the off-patent biologicals market, the Belgian government needs to evolve from the introduction of ad hoc measures to the formation of a long-term, consistent, integrated policy framework that is built on four pillars:

i) the creation of a proactive and transparent climate supporting a level playing field for both biosimilar and reference product, including horizon scanning, a multi-stakeholder approach, leadership, protocols for switching with best practice case studies, and 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, supported by guidance for hospitals on future entry of biosimilars and which tender criteria to consider, accompanied by close follow-up
iv) the development of physician incentives that focus on decreasing workload and/or improving patient care.

The implementation of these pillars will be critical to benefit from the full potential of biosimilars.

Conflict of interest
The authors of the research paper [1] reported conflict of interest, including being involved in consulting, advisory work and speaking engagements for a number of pharmaceutical companies. For full details of the authors’ conflict of interest, see the research paper [1].

Abstracted by Evelien Moorkens, PhD Researcher Market Access Biosimilars, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium.

Related article
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Reference
1. Moorkens E, Vulto AG, Huys I. Biosimilars in Belgium: a proposal for a more competitive market. Acta Clin Belg. 2020:1-12.10.1080/17843286.2020.1761690

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