Capturing the holistic value of biosimilars in Europe – part 1: a historical perspective

Figures & data

Table 1. Summary of instruments used to drive price evolution and uptake of biosimilar medicines in Europe^a.

Instrument	Example markets^b	Advantages	Disadvantages
Price controls
Mandated price discount of biosimilar from reference product	CZ, FI, PL, RU	Guaranteed cost-savings to the healthcare system	May disincentivize development of biosimilars
Mandated price discount from previous biosimilar launches	AT, HR, LV, RS	Increasing cost-savings are guaranteed for the healthcare system	Increasingly reduced revenue potential may disincentivize development of additional biosimilars and limit market competition
Mandated price cut of reference product	AT, BE, IS	Guaranteed cost-savings to the healthcare system	Could disincentivize manufacturers of reference products to remain in the market
Prescription policies
Mandated switching to lowest-cost option	DK, NO, PL	Drives uptake of lowest-cost option and therefore cost-savings	In the past, this initiated debate on the safety of switching and could disincentivize manufacturers of both biosimilars and reference products to try to compete in the future
Guidelines recommending switching to lowest-cost option	UK, DE	Drives uptake of lowest-cost option and therefore cost-savings	Need patient, nurse, and prescriber support (relies on patient and prescriber compliance)
Prescription guidance, quotas, and monitoring	DE, IT, SE, ES, UK	Ensures biosimilar prescribing, increasing uptake	Requires robust monitoring and may reduce physician prescribing freedom
Financial incentives
Share of savings	DE, FR, IT, SE, UK	Promotes use of biosimilars and reinvests cost-savings to HCPs	May increase administrative burden and pose a challenge to implement widely
Financial penalties	DE, IT, MT	Incentivizes biosimilar prescribing	Physicians may perceive reduced prescribing freedom and obstruct/direct to other product out of sight

AT=Austria; BE=Belgium; CZ=Czech Republic; DE=Germany; DK=Denmark; ES=Spain; FI=Finland; FR=France; HR=Croatia; IS=Iceland; IT=Italy; LV=Latvia; MT=Malta; NO=Norway; PL=Poland; RS=Serbia; RU=Russian Federation; SE=Sweden; UK=United Kingdom.

^aSources include 30 one-on-one interviews and an online questionnaire (103 respondents), in addition to other published reference materials [5,9].

^bNot an exhaustive list.

Figure 1. Surveyed European stakeholders’ perception of (a) patient benefits resulting from biosimilar competition; (b) changes to access of biologics after biosimilar competition; and (c) the drivers causing changes to access of biologics after biosimilar competition.

^aSubcutaneous or citrate-free formulations.

SC=subcutaneous.

Table 2. Summary of the three stages of the market maturity framework for biologic benefit.

	Primary opportunities	Main biosimilar benefit
Invest	Offer the first opportunity for treatment with biologics	Lower-cost biosimilars allow markets to provide access to biologic therapies, where previously these were too costly
Expand	Expand access to biologics to a greater number of patients	Cost-savings from biosimilars allow expanded access to biologic therapies, treating an increased number of patients
Harvest	Appropriately recycle cost-savings Sustain biosimilar competition	Competition of multiple manufacturers for stable, lower-cost supply of biologics while driving innovation

Table 3. Financial flow archetypes.

Archetype	Possible implications for cost-savings
Provider benefit Cost-savings are retained where the biologic medicine is prescribed (e.g. hospital department/specialist centers)	Savings are a direct benefit to the local provider Local budgets are expected to remain unaffected in future years
Purchaser benefit Cost-savings retained by the institution or organization that procures the biologic medicine (e.g. healthcare payer organization)	Savings are lost to the local provider but kept within the healthcare system Healthcare budgets are expected to remain unaffected in future years
Ultimate payer benefit Cost-savings retained by the ultimate payer of biologic medicine (i.e. national or regional government budget)	Savings remain beneficial but are not necessarily kept within the healthcare system Healthcare budgets could be reduced in future years to a newly established ‘baseline’

Figure 2. Evolution of price per treatment days (biosimilars and reference product) and biosimilar market share for anti-TNF and oncology biologics in selected European countries, from the year before biosimilar entry to June 2020 (data extracted from, the impact of biosimilar competition in Europe, 2020 [11]).

AT=Austria; BE=Belgium; CZ=Czech Republic; DE=Germany; DK=Denmark; ES=Spain; FR=France; HU=Hungary; IT=Italy; LV=Latvia; MAT=moving annual total; NL=Netherlands; NO=Norway; PL=Poland; RU=Russian Federation; SE=Sweden; SL=Slovenia; TD=treatment days; TNF=tumor necrosis factor; UK=United Kingdom; YR=year.

Figure 3. Long-term view on list price savings from biosimilar competition. Yearly savings from biosimilar competition (cost for post-biosimilar volume at pre-biosimilar list prices) (reproduced from, the impact of biosimilar competition in Europe, Troein, P., Newton, M., Scott, K. © IQVIA Inc. 2021; by permission of IQVIA Inc [2])^a.

^aIQVIA MIDAS™ data from 2006 – 2020, using Euros at constant exchange rates; 14 originator products with approved biosimilars from 2006 – 2020 (includes biosimilar and originator), covering the full European Economic Area (33 countries), calculated volume is in treatment days determined by the World Health Organization Defined Daily Dose (DDD), and where values are unavailable via Oncology Dynamics Physician Survey (2017) DDD estimates.

Figure 4. Uptake of infliximab biosimilar since its launch across European markets (reproduced from, leveraging biosimilars for better access and lower cost, Troein, P. Source: IQVIA MIDAS restricted MTH Oct 2017, © IQVIA Inc. 2017, by permission of IQVIA Inc [27]).

Figure 5. Change in volume of adalimumab uptake from the year before biosimilar entry to the year ending Q1/2020 across various European markets (reproduced from, country scorecards for biosimilar sustainability, methodology appendix. © IQVIA and its affiliates. 2020; by permission of IQVIA Inc [60]).

DE=Germany; DK=Denmark; ES=Spain; FR=France; HU=Hungary; IT=Italy; NL=Netherlands; NO=Norway; PL=Poland; RO=Romania; SE=Sweden; TD=treatment days; UK=United Kingdom.

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Data availability statement

All original data are contained within Figure 1 or in the article text.