The Expiry of Humira ® Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe: An Overview of Pricing and National Policy Measures

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. The aim of this paper is to provide a European overview of (list) prices of originator...

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Published in:	Frontiers in pharmacology Vol. 11; p. 591134
Main Authors:	Moorkens, Evelien, Godman, 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
Format:	Journal Article
Language:	English
Published:	Switzerland Frontiers Media S.A 08-01-2021
Subjects:	adalimumab biosimilars competition Europe Humira Medicin och hälsovetenskap Pharmacology prices health policy Europe biosimilars Humira competition prices adalimumab
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Summary:	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. 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. 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. 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. 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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Edited by: Jean Paul Deslypere, Aesculape CRO, Belgium Mihajlo Jakovljevic, Hosei University, Japan This article was submitted to Pharmaceutical Medicine and Outcomes Research, a section of the journal Frontiers in Pharmacology Reviewed by: Filippo Drago, University of Catania, Italy
ISSN:	1663-9812 1663-9812
DOI:	10.3389/fphar.2020.591134