A recent publication by Barcina Lacosta et al. reflected on the need to understand market dynamics generated following biosimilars availability in Southern Europe, emphasizing that the competitive potential of biosimilars can be further deployed [1]. Considering the country-, setting-, and product-specific nature of biosimilar uptake patterns [2-5], the authors focused the analysis on hospital tumour necrosis factor alpha (TNF-α) inhibitor markets in Italy, Portugal and Spain [1].
Diverse policies and information campaigns have been launched in Italy, Portugal and Spain to support biosimilar adoption in clinical practice. Despite these measures and the increased stakeholders’ familiarity with biosimilars, barriers persist that limit their uptake, especially in patient populations with chronic conditions and that are eligible for therapy switches, i.e. originator-to-biosimilar, biosimilar-to-originator and biosimilar-to-biosimilar switches. This is reflected in the low uptake (below 25%) of TNF-α inhibitor biosimilars in certain regions, even after six years of biosimilar market availability [1].
In the countries of study, hospital pharmacists and managers have been primarily responsible for supporting rational prescribing objectives and fostering biosimilar adoption. Barcina Lacosta et al. indicated that this mission has however been affected by:
1) The late publication of position statements on biosimilars interchangeability by regulatory health authorities.
2) The vague positioning of reference institutions on best switching practices.
3) Policy frameworks that do not necessarily support the initiation of switching protocols.
4) Purchasing procedures that limit biosimilars competitive potential.
The authors signalled the limited reach of local initiatives implemented to support biosimilar adoption, if not supported by a national policy framework. It was concluded that there is a need for the coordinated implementation of policy measures at the local/regional and national level in Italy, Portugal and Spain. These measures should jointly consider supply- and demand-side challenges.
Conflict of interest
The authors of the research paper reported conflict of interest [1], including being a founder of the KU Leuven Fund on Market Analysis of Biologics and Biosimilars following Loss of Exclusivity (MABEL), as well as being involved in a stakeholder roundtable, having participated in advisory board meetings and having contributed to studies on biologicals and biosimilars. For full details of the authors’ conflict of interest, see the research paper.
Abstracted by Teresa Barcina Lacosta, PhD Researcher Pharmacological Sciences, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium.
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Key factors for successful uptake of biosimilars: Europe and the US
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References
1. Barcina Lacosta T, Vulto AG, Huys I, et al. An exploration of biosimilar TNF-alpha inhibitors uptake determinants in hospital environments in Italy, Portugal, and Spain. Front Med. 2023;9
2. Moorkens E, Simoens S, Troein P, et al. Different policy measures and practices between Swedish counties influence market dynamics: part 1-biosimilar and originator infliximab in the hospital setting. BioDrugs. 2019;33(3):285-97.
3. Moorkens E, Barcina Lacosta T, Vulto AG, et al. Learnings from regional market dynamics of originator and biosimilar infliximab and etanercept in Germany. Pharmaceuticals (Basel). 2020;13(10):324.
4. Moorkens E, Vulto AG, Kent J, et al. A look at the history of biosimilar adoption: characteristics of early and late adopters of infliximab and etanercept biosimilars in subregions of England, Scotland and Wales - a mixed methods study. BioDrugs. 2021;35(1):75-87.
5. Rémuzat C, Dorey J, Cristeau O, et al. Key drivers for market penetration of biosimilars in Europe. J Mark Access Health Policy. 2017;5(1):1272308.
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