MONOCLONAL ANTIBODIES BIOSIMILARS IN THE US- WHAT LESSONS CAN BE DRAWN FROM THE RECENT EUROPEAN, SOUTH KOREAN AND JAPANESE EXPERIENCE?
Author(s)
Bocquet F1, Loubiere A1, Paubel P2
1Faculté of pharmacy, Paris Descartes University, Sorbonne Paris Cité, Paris, France; Health Law Institute, Inserm, UMR S 1145, Paris Descartes Université, Sorbonne Paris Cité, Paris, France, Paris, France, 2General Agency of Equipment and Health Products (AGEPS), Assistance Publique-Hôpitaux de Paris (AP-HP) ; Faculté of pharmacy, Paris Descartes University, Sorbonne Paris Cité, Paris, France, Paris, France
OBJECTIVES: This study aims to assess the level of competition between the first monoclonal antibodies (mAbs) biosimilars, i.e. infliximab biosimilars (BIOSIM-INFLIX) and their originator (Remicade/infliximab, J&J/Merck) (ORIGIN-INFLIX) by analyzing the key global infliximab markets and the drivers of the BIOSIM-INFLIX uptakes. METHODS: Data on medicine volumes, values and ex-manufacturing prices for BIOSIM-INFLIX and ORIGIN-INFLIX in the EU, in South Korea and in Japan from January 2016 to June 2016 were provided by IMS Health. Volumes were calculated in DDD (Defined Daily Doses) and Weighted Average Price (WAP) in Euros/DDD. RESULTS: In the first half of 2016, the highest BIOSIM-INFLIX uptake was found in Denmark (96.4%), while the lowest was reported in Japan (1.7%). In EU countries where BIOSIM-INFLIX were marketed in 2015, their uptakes are between 10% and 30% (e.g. France, Germany, Spain, Italy and the UK with respectively 11.5%, 16.9%, 20.8%, 25.5% and 25.6%), in the same way as for countries where BIOSIM-INFLIX have been marketed since 2013 (e.g. Czech Republic and Portugal with respectively 24.9% and 23.0% uptakes), except Finland (66.4%) and Norway (86.7%). All countries have dominant hospital distributions for infliximab except Germany, Japan and Czech Republic, which have mixed retail/hospital distributions. Germany is the country where BIOSIM-INFLIX is the most expensive (WAP=€21.8/DDD) and Norway the country where it is the cheapest (WAP=€4.8/DDD with a 66.2% discount versus ORIGIN-INFLIX). However, the relative price of BIOSIM-INFLIX versus ORIGIN-INFLIX does not always seem correlated to BIOSIM-INFLIX uptakes (e.g. in South Korea, the BIOSIM-INFLIX uptake was 28.6%, whereas the WAP difference between BIOSIM-INFLIX and ORIGIN-INFLIX was of -4.3%; in Japan, the BIOSIM-INFLIX uptake was 1.7% whereas this difference amounts to -33.5%). CONCLUSIONS: Infliximab markets have proven to be highly country-specific. Today, the competition between BIOSIM-INFLIX and ORIGIN-INFLIX does not seem to be mainly based on prices, but on local decision-making and purchasing process.
Conference/Value in Health Info
2017-05, ISPOR 2017, Boston, MA, USA
Value in Health, Vol. 20, No. 5 (May 2017)
Code
PHP27
Topic
Economic Evaluation, Health Policy & Regulatory, Health Service Delivery & Process of Care
Topic Subcategory
Cost/Cost of Illness/Resource Use Studies, Formulary Development, Prescribing Behavior, Pricing Policy & Schemes
Disease
Gastrointestinal Disorders, Musculoskeletal Disorders, Sensory System Disorders
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