Key drivers for market penetration of biosimilars in Europe

ABSTRACT

Background & Objectives: Potential drivers and barriers of biosimilar uptake were mainly analysed through qualitative approaches. The study objective was to conduct a quantitative analysis and identify drivers of biosimilar uptake of all available biosimilars in the European Union (EU).

Methods: A three-step process was established to identify key drivers for the uptake of biosimilars in the top 10 EU member states (MS) pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden, and the UK): (1) literature review to identify incentive policies in place to enhance biosimilars adoption; (2) assessment of biosimilar market dynamics based on database analysis; (3) regression model analysis on price using the following explicative variables: incentive policies; price difference between the biosimilar and the originator product; distribution channel; generic uptake and generic price cut; pharmaceutical expenditure per capita; and market competition.

Results: At the study cut-off date, 20 biosimilars were available on the market. Incentive policies applied to biosimilars were found to be heterogeneous across countries, and uptakes of biosimilars were also very heterogeneous between different therapeutic classes and countries. Results from the model demonstrated that incentive policies and the date of first biosimilar market entry were correlated to biosimilar uptake. Pharmaceutical expenditure per capita and the highest generic uptake were inversely correlated with biosimilar uptake. Average generic price discount over originator and the number of biosimilars showed a trend toward statistical significance for correlation with biosimilar uptake, but did not reach the significance threshold. Biosimilar price discount over original biologic price, the number of analogues, and the distribution channel were not correlated with the biosimilar uptake.

Conclusions: Understanding drivers of biosimilar uptake becomes a critical issue to inform policy decision-makers. This study showed that incentive policies to enhance uptake remain an important driver of biosimilar penetration, while biosimilar price discounts have no impact. Future research is warranted when the biosimilar market gains maturity.

KEYWORDS:

• Biosimilar
• uptake
• Europe
• price erosion
• market dynamics
• incentive policies

Disclosure statement

This research has been funded by Sandoz International GmbH.

Notes

¹ Health status indicators: life expectancy at birth; at 65; mortality from cardiovascular diseases.

² Risk factors indicators: smoking in adults; alcohol consumption; obesity in adults; overweight and obesity in children.

³ Access to care indicators: healthcare coverage; share of out of pocket medical expenditure in household consumption; unmet medical care needs; unmet dental care needs; waiting time for cataract surgery; waiting time for knee replacement.

⁴ Quality of care indicators: asthma and COPD hospital admission; diabetes hospital admission; case-fatality for acute myocardial infarction; case-fatality for ischemic stroke; cervical cancer survival; breast cancer survival; colorectal cancer survival.

⁵ Health care resources indicators: health expenditure per capita; doctors per capita; nurses per capita; hospital beds per capita; MRI units per capita; CT scanners per capita.