Presentation (CTI)

OBJECTIVES: Assess whether having a price linkage policy, which requires price cuts for originators upon patent expiry and/or capping generic/biosimilar prices against the originator’s, is associated with higher price declines for biologics and biosimilars.
METHODS: Price trends for biologics and biosimilars at biosimilar launch and 12 months later were calculated for products first experiencing biosimilar competition between January 2016 and May 2026 in the 48 countries with GlobalData pricing and reimbursement profiles. Price trends were compared for countries which practice price linkage vs those which do not, using list prices from GlobalData’s POLI database.
RESULTS: Twenty-six of the 48 countries use price linkage; one was excluded due to insufficient price data. The average price decline was 6% at biosimilar launch for the off-patent biologic in the countries with price linkage, compared to 2% in countries without. In countries practicing price linkage biosimilars were priced 23% lower than the originator at launch, but the price differential dropped to 17% a year later. The price differential in countries without price linkage was 24% at launch, rising to 28% a year later. At one year after biosimilar launch, prices of off-patent biologics had dropped 16% in countries without price linkage, compared to 18% in no-price-linkage countries; for biosimilars prices fell 4% in price-linkage countries, compared to 14% in no-price-linkage countries.
CONCLUSIONS: Use of price linkage is associated with steeper price cuts for off-patent biologics and higher price differential from biosimilars at launch. However, price linkage appears to result in lower price erosion over time for both off-patent originator and biosimilar by encouraging companies to price the product close to the maximum level allowed by the price linkage policy. Variation between countries within the same set (price-linkage vs no-price-linkage) in price differential and price erosion can be explained by differences in their price-linkage requirements.