Presentation (CTI)

OBJECTIVES: With blockbuster therapies such as Keytruda expected to lose exclusivity shortly, the aim of this analysis is to understand the potential pricing implications on reference biologics and biosimilars upon patent expiration and to create a matrix according to market impact of biosimilar entry.
METHODS: Using GlobalData’s Price Intelligence (POLI) database, off-patent biologics facing competition from biosimilars were selected across 61 markets. In each instance, the first biosimilar that was priced matching the first pack of the originator drug on the market was considered. A risk rating system of 1-5 was then created based on: 1) average duration of time (in days) until the originator underwent a price change due to biosimilar market entry in a country; 2) the average percentage price drop that was triggered for the originator upon biosimilar entry in each country.
RESULTS: Of the 61 markets reviewed, 13 countries received the highest rating (5), representing countries with an average price reduction of the originator by 10% or greater in the first year of the biosimilar’s market entry. The most common rating was 4, which represented 30% of markets reviewed. Of the 61 markets, 26 utilize price linkage policies, of which 18 had higher risk ratings of 3 to 5.
CONCLUSIONS: Markets such as Japan, Ireland, South Korea pose some of the greatest risk to biologics that are going off-patent. Stringent price linkage policies apply in these countries as part of cost containment, and consequently, they see some of the most significant price reductions for originator biologics, between 14% to 28%, and at the fastest rates. Price reductions were triggered on average between 97 days (South Korea) to 270 days (Japan) after the entry of the biosimilar.