TY - JOUR
T1 - The Expiry of Humira® Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe
T2 - An Overview of Pricing and National Policy Measures
AU - Moorkens, Evelien
AU - Godman, Brian
AU - Huys, Isabelle
AU - Hoxha, Iris
AU - Malaj, Admir
AU - Keuerleber, Simon
AU - Stockinger, Silvia
AU - Mörtenhuber, Sarah
AU - Dimitrova, Maria
AU - Tachkov, Konstantin
AU - Vončina, Luka
AU - Palčevski, Vera Vlahović
AU - Achniotou, Gnosia
AU - Slabý, Juraj
AU - Popelková, Leona
AU - Kohoutová, Kateřina
AU - Bartels, Dorthe
AU - Laius, Ott
AU - Martikainen, Jaana E.
AU - Selke, Gisbert W.
AU - Kourafalos, Vasileios
AU - Magnússon, Einar
AU - Einarsdóttir, Rannveig
AU - Adams, Roisín
AU - Joppi, Roberta
AU - Allocati, Eleonora
AU - Jakupi, Arianit
AU - Viksna, Anita
AU - Greičiūtė-Kuprijanov, Ieva
AU - Vella Bonanno, Patricia
AU - Suttorp, Vincent
AU - Melien, Øyvind
AU - Plisko, Robert
AU - Mardare, Ileana
AU - Meshkov, Dmitry
AU - Novakovic, Tanja
AU - Fürst, Jurij
AU - Zara, Corinne
AU - Marković-Peković, Vanda
AU - Grubiša, Nataša
AU - Befrits, Gustaf
AU - Puckett, Robert
AU - Vulto, Arnold G.
N1 - Publisher Copyright:
© 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.
PY - 2021/1/8
Y1 - 2021/1/8
N2 - 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.
AB - 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.
KW - Europe
KW - Humira
KW - adalimumab
KW - biosimilars
KW - competition
KW - health policy
KW - prices
UR - http://www.scopus.com/inward/record.url?scp=85099607758&partnerID=8YFLogxK
U2 - 10.3389/fphar.2020.591134
DO - 10.3389/fphar.2020.591134
M3 - Article
C2 - 33519450
AN - SCOPUS:85099607758
SN - 1663-9812
VL - 11
JO - Frontiers in Pharmacology
JF - Frontiers in Pharmacology
M1 - 591134
ER -