Introductory remarks to the Breakout Session
Valérie Paris – Health Division
Challenges to address product hopping in biologics
Who is assessing the benefits for health systems and patients?
From intra-venous to sub-cutaneous version of injectable biologics
Trastuzumab SC Launch in Netherlands
What are the drivers of biosimilar uptapke?
1. Biosimilar uptake has generally increased over time, but uptake varies widely by country and therapeutic areas
Uptake of biosimilars across countries, per therapeutic area 2016-2024 Source:
Market share of biosimilars in biologic market in ten key therapy areas, 2023
Biosimilar uptake is important for access and efficiency – « non-referenced markets » are big in some EU countries
Note: The accessible market includes three categories: reference medicines (originator biologics for which a biosimilar exists), non-referenced market (biologics that have lost patent protection but do not have an approved biosimilar), and biosimilars. Originator biologics that are still under patent protection are excluded from the accessible market. Volume sales are measured in treatment days,
Source: IQVIA MIDAS® 2023.
Price regulation vs competition across countries and market segments
Do confidential rebates harm or serve competition?
AOn-patent medicines, price regulation
(most OECD countries, for outpatient, reimbursed pharma)
Different types of contracts, with immediate or postponed rebates
Actual price not disclosed, sometimes only knonwn “ x-p ” ( .g. volume based or outcome based agreements)
Off-patent medicines, price regulation
(often defined as a share of originator's price)
Price regulation and competition n market segments
B
On-patent medicines not subject to price regulation
OTC medicines
United States: lots of discounts to intermediaries, actual transaction
price not known. Other countries: most medicines directly purchased by hospitals – bilateral negotiation or tendering
Off-patent medicines, in competition
Hospital tendering, procurement prices generally not known
Netherlands, Germany)
Share of generics in the pharmaceutical market by volume, 2023 and 2013 (or nearest year)
1. Reimbursed pharmaceutical market, i.e. the sub-market in which a third-party payer reimburses medicines. 2. Community pharmacy market. 3. Latest data from 2021-2022. Source: OECD Health Statistics 2025.