The Expiry of Humira Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe: An Overview of Pricing and National Policy Measures.
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Authors
Moorkens, EvelienGodman, Brian
Huys, Isabelle
Hoxha, Iris
Malaj, Admir
Keuerleber, Simon
Stockinger, Silvia
Mörtenhuber, Sarah
Dimitrova, Maria
Tachkov, Konstantin
Vončina, Luka
Palčevski, Vera Vlahović
Achniotou, Gnosia
Slabý, Juraj
Popelková, Leona
Kohoutová, Kateřina
Bartels, Dorthe
Laius, Ott
Martikainen, Jaana E
Selke, Gisbert W
Kourafalos, Vasileios
Magnússon, Einar
Einarsdóttir, Rannveig
Adams, Roisín
Joppi, Roberta
Allocati, Eleonora
Jakupi, Arianit
Viksna, Anita
Greičiūtė-Kuprijanov, Ieva
Vella Bonanno, Patricia
Suttorp, Vincent
Melien, Øyvind
Plisko, Robert
Mardare, Ileana
Meshkov, Dmitry
Novakovic, Tanja
Fürst, Jurij
Zara, Corinne
Marković-Peković, Vanda
Grubiša, Nataša
Befrits, Gustaf
Puckett, Robert
Vulto, Arnold G
Issue Date
2021-01-08
Metadata
Show full item recordCitation
Moorkens E, Godman B, Huys I, Hoxha I, Malaj A, Keuerleber S, et al. The Expiry of Humira(®) Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe: An Overview of Pricing and National Policy Measures. Frontiers in pharmacology. 2020;11:591134.doi:10.3389/fphar.2020.591134.Abstract
Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry. Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures. Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab. Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80-90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 - €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures. Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Countries with biosimilars on the market seem to have competition lowering list or actual prices. Reported discounts varied widely between countries.Description
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https://www.frontiersin.org/articles/10.3389/fphar.2020.591134/fullhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7839249/
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Copyright © 2021 Moorkens, Godman, Huys, Hoxha, Malaj, Keuerleber, Stockinger, Mörtenhuber, Dimitrova, Tachkov, Vončina, Palčevski, Achniotou, Slabý, Popelková, Kohoutová, Bartels, Laius, Martikainen, Selke, Kourafalos, Magnússon, Einarsdóttir, Adams, Joppi, Allocati, Jakupi, Viksna, Greičiūtė-Kuprijanov, Vella Bonanno, Suttorp, Melien, Plisko, Mardare, Meshkov, Novakovuc, Fürst, Zara, Marković-Peković, Grubiša, Befrits, Puckett and Vulto.ae974a485f413a2113503eed53cd6c53
10.3389/fphar.2020.591134
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