Overview
Biosimilars have been available in Europe for over a decade, and have offered the opportunity to vastly reduce the cost of treatment for a large number of biologic agents. In order to deliver significant savings to the healthcare structure of each individual EU member state, a careful inspection of the market access, pricing, and reimbursement mechanisms in force in each region is paramount. An in-depth knowledge of what drives payer and physician decision-making on biosimilar use is crucial for biosimilar developers wishing to design market access strategies uniquely tailored to the specific demands in each EU member state.
This analysis summarizes key information on the process of biosimilar approval in Europe, along with associated challenges, and provides highlights on country-specific market access, pricing, and reimbursement mechanisms which drive biosimilar uptake or prove a barrier to their entrance.
Biosimilars have been available in Europe for over a decade, and have offered the opportunity to vastly reduce the cost of treatment for a large number of biologic agents. In order to deliver significant savings to the healthcare structure of each individual EU member state, a careful inspection of the market access, pricing, and reimbursement mechanisms in force in each region is paramount. An in-depth knowledge of what drives payer and physician decision-making on biosimilar use is crucial for biosimilar developers wishing to design market access strategies uniquely tailored to the specific demands in each EU member state.
This analysis summarizes key information on the process of biosimilar approval in Europe, along with associated challenges, and provides highlights on country-specific market access, pricing, and reimbursement mechanisms which drive biosimilar uptake or prove a barrier to their entrance.
Table of Contents
EXECUTIVE SUMMARYA regulatory pathway governing biosimilars in Europe has existed for over a decade
Biosimilar developers need to overcome a plethora of IP and legal obstacles
Biosimilar naming and labeling in the EU is uniform
European countries have comparable views on substitution and switching
Global trends in biosimilar uptake in the five major EU markets
Gain-sharing and CQUIN targets are key payer measures to drive biosimilar uptake in the UK
Prescribing quotas and contracting for preferred biosimilars targets are key payer measures to drive biosimilar uptake in Germany
Hospital-level price differentials between expensive liste-en-sus therapies and tender prices are a key payer measure to drive biosimilar uptake in France
Biosimilar prescription quotas and regional negotiations are key payer measures to drive biosimilar uptake in Spain
Budget constraints are key payer measures to drive biosimilar uptake in Italy
BIOSIMILAR REGULATORY PATHWAY
Insights and strategic recommendations
The European regulatory pathway for biosimilar approval has been available for over a decade
The European Commission has established the legal basis for the approval of biosimilars in the EU
The EMA has released guidance on biosimilar approval requirements
The regulatory requirements for biosimilar development are outlined in the guideline
Indication extrapolation is based on a comprehensive data package
The concept of interchangeability in the EU differs from the US
Omnitrope was the first biosimilar molecule approved in the EU
Inflectra/Remsima is the first biosimilar monoclonal antibody approved in the EU
The EMA has approved 38 biosimilar medicines in 14 different classes
Bibliography
INTELLECTUAL PROPERTY AND LEGAL ISSUES
Insights and strategic recommendations
There are numerous intellectual property and legal issues associated with biosimilars
The European Patent Organisation issues bundles of patents to its member states
The Unitary Patent system will create a single-patent system for EU member states
Challenging originator molecule patents is a common feature of biosimilar development
Bibliography
NAMING AND LABELING
Insights and strategic recommendations
Biosimilar naming and labeling is uniform across European countries
Bibliography
SUBSTITUTION AND SWITCHING
Insights and strategic recommendations
There are nuances in the EMA definitions of biosimilar interchangeability, substitution, and switching
Current position of EU countries on switching and substitution
Bibliography
PAYER TOOLS TO DRIVE BIOSIMILAR UPTAKE
Insights and strategic recommendations
Payers implement a wide variety of tools to drive biosimilar uptake
Educating stakeholders is crucial for biosimilar uptake
PAYER VIEWS AND TRENDS
Insights and strategic recommendations
Biosimilar uptake varies across EU markets as the EMA does not determine interchangeability
There are country-specific differences in biosimilar pricing, but the need for a substantial discount is universal
Hospitals continue to procure both biosimilars and originators
Availability of Herceptin and Rituxan in a patent-protected SC formulation is only a minor barrier to biosimilar entry
Bibliography
FRANCE
Insights and strategic recommendations
The TC evaluates new drugs and sets ASMR ratings, with impacts on drug pricing
CEPS requires a reduction in the reimbursement price of biologics dispensed outside of hospitals upon biosimilar entry
Payer measures to drive uptake
Bibliography
GERMANY
Insights and strategic recommendations
Manufacturers are free to set biosimilar prices in Germany
Payer measures to drive uptake
Uptake of most biosimilar products in Germany has been high
Bibliography
ITALY
Insights and strategic recommendations
AIFA considers all biosimilar applications in Italy
AIFA issued a concept paper on biosimilars to clarify the legal framework around biosimilar procurement and use
Biosimilars in Italy are required to offer at least 20% discount on the price of their originators
Drivers and resistors to biosimilar use in Italy
The prevalent use of biosimilars in Italy is in biologic-naïve patients, but switching experienced patients onto a biosimilar also occurs
The key drivers to biosimilar uptake in Italy are budget constraints and guidelines encouraging the use of cheaper options
Certain regions set provisions to regulate biologic prescription and control expenditure
Bibliography
SPAIN
Insights and strategic recommendations
Biosimilars in Spain should be priced 30% lower than their branded counterpart
Payer measures to drive uptake
Bibliography
UK
Insights and strategic recommendations
The UK has a free pricing system for biosimilars
CCGs are responsible for a large proportion of commissioning but NHS England is the payer for biosimilars in oncology
Tendering and procurement in the UK is a complex process
Biosimilars in the UK are not viewed as interchangeable
Payer measures to drive biosimilar uptake in the UK
Biosimilar adoption has been a relative success in the UK
Biosimilar adoption varies depending on region and molecule
Bibliography
BIOSIMILAR DIFFERENTIATION
Added services are viewed as valuable by some payers
Availability of pre-filled infusion bags is a valuable service to UK payers
Product presentation and packaging may matter more than expected
Identity of the company matters but consistency of supply is more important
Bibliography
METHODOLOGY
Primary research
List of Figures
Figure 1: Drivers and resistors to biosimilar use in France
Figure 2: Drivers and resistors to biosimilar use in Germany
Figure 3: Drivers and resistors to biosimilar use in Italy
Figure 4: Drivers and resistors to biosimilar use in Spain
Figure 5: Drivers and resistors to biosimilar use in the UK
List of Tables
Table 1: List of biosimilar guidelines issued by the EMA
Table 2: Biosimilars with marketing authorization in the EU by the EC, following an assessment by the EMA’s CHMP, 2006-17
Table 3: EMA definitions of biosimilar interchangeability, substitution, and switching
Table 4: Overview of the general opinions on automatic substitution and switching in the five major EU markets
Table 5: Position statements on automatic substitution and switching: EU-wide organizations
Table 6: Position statements on automatic substitution and switching in the UK
Table 7: Position statements on automatic substitution and switching in Germany
Table 8: Position statements on automatic substitution and switching in France
Table 9: Position statements on automatic substitution and switching in Italy
Table 10: Position statements on automatic substitution and switching in Spain
Table 11: Biosimilar market access overview in the five major EU markets
Table 12: ASMR ratings and pricing implications
