The entry of adalimumab biosimilars in Europe : an overview of price evolution and country responses

Background: From October 2018, adalimumab biosimilars could enter the European market. However, some countries, such as the Netherlands, report high discounts for the originator product that influence biosimilar entry. Consequently, we researched European (list) prices and reimbursement status of originator adalimumab, before and after the entry of biosimilars, and discuss relevant policy measures. Methods: Survey distributed via email to national experts consisting of three parts: i) general financing/co-payment of medicines, ii) reimbursement status and prices of originator adalimumab and availability of biosimilars, and iii) policy measures related to the use of adalimumab. Results: In the 27 surveyed countries, originator adalimumab is reimbursed (fully or only partial, and sometimes with restrictions in use), except for Kosovo, where it is not marketed. Following adalimumab biosimilars, a few countries have made changes to the reimbursement status/level or setting where adalimumab is available. Overall, a decrease in list prices of originator adalimumab was seen after loss of exclusivity rights. Some countries (Bulgaria, Germany, Greece, Italy, Latvia, the Netherlands and Romania) reported that list prices have not changed up to May 2019, although confidential discounts may exist. Adalimumab biosimilars were available in 23 of the 27 surveyed countries. Countries adopted various approaches to leverage competition from the use of (biosimilar) adalimumab. In some countries, a strategy was implemented even before patent expiry (Scotland), while others did not report specific measures. Conclusion: This study documented how European countries responded differently to patent expiry of originator adalimumab and biosimilar market entry, with implications for pricing and reimbursement