TABLE OF CONTENTS

7 EXECUTIVE SUMMARY
7 A regulatory pathway governing biosimilars in Europe has existed for over a decade
7 Biosimilar developers need to overcome a plethora of IP and legal obstacles
7 Biosimilar naming and labeling in the EU is uniform
7 European countries have comparable views on substitution and switching
8 Global trends in biosimilar uptake in the five major EU markets
8 Gain-sharing and CQUIN targets are key payer measures to drive biosimilar uptake in the UK
8 Prescribing quotas and contracting for preferred biosimilars targets are key payer measures to drive biosimilar uptake in Germany
8 Hospital-level price differentials between expensive liste-en-sus therapies and tender prices are a key payer measure to drive biosimilar uptake in France
9 Biosimilar prescription quotas and regional negotiations are key payer measures to drive biosimilar uptake in Spain
9 Budget constraints are key payer measures to drive biosimilar uptake in Italy

10 BIOSIMILAR REGULATORY PATHWAY
10 Datamonitor Healthcare insights and strategic recommendations
10 The European regulatory pathway for biosimilar approval has been available for over a decade
10 The European Commission has established the legal basis for the approval of biosimilars in the EU
10 The EMA has released guidance on biosimilar approval requirements
13 The regulatory requirements for biosimilar development are outlined in the guideline
16 Indication extrapolation is based on a comprehensive data package
16 The concept of interchangeability in the EU differs from the US
16 Omnitrope was the first biosimilar molecule approved in the EU
17 Inflectra/Remsima is the first biosimilar monoclonal antibody approved in the EU
17 The EMA has approved 38 biosimilar medicines in 14 different classes
20 Bibliography

22 INTELLECTUAL PROPERTY AND LEGAL ISSUES
22 Datamonitor Healthcare insights and strategic recommendations
22 There are numerous intellectual property and legal issues associated with biosimilars
23 The European Patent Organisation issues bundles of patents to its member states
24 The Unitary Patent system will create a single-patent system for EU member states
24 Challenging originator molecule patents is a common feature of biosimilar development
25 Bibliography

27 NAMING AND LABELING
27 Datamonitor Healthcare insights and strategic recommendations
27 Biosimilar naming and labeling is uniform across European countries
28 Bibliography

29 SUBSTITUTION AND SWITCHING
29 Datamonitor Healthcare insights and strategic recommendations
29 There are nuances in the EMA definitions of biosimilar interchangeability, substitution, and switching
30 Current position of EU countries on switching and substitution
44 Bibliography

46 PAYER TOOLS TO DRIVE BIOSIMILAR UPTAKE
46 Datamonitor Healthcare insights and strategic recommendations
46 Payers implement a wide variety of tools to drive biosimilar uptake
54 Educating stakeholders is crucial for biosimilar uptake

56 PAYER VIEWS AND TRENDS
56 Datamonitor Healthcare insights and strategic recommendations
56 Biosimilar uptake varies across EU markets as the EMA does not determine interchangeability
61 There are country-specific differences in biosimilar pricing, but the need for a substantial discount is universal
68 Hospitals continue to procure both biosimilars and originators
70 Availability of Herceptin and Rituxan in a patent-protected SC formulation is only a minor barrier to biosimilar entry
72 Bibliography

73 FRANCE
73 Datamonitor Healthcare insights and strategic recommendations
73 The TC evaluates new drugs and sets ASMR ratings, with impacts on drug pricing
74 CEPS requires a reduction in the reimbursement price of biologics dispensed outside of hospitals upon biosimilar entry
75 Payer measures to drive uptake
82 Bibliography

84 GERMANY
84 Datamonitor Healthcare insights and strategic recommendations
84 Manufacturers are free to set biosimilar prices in Germany
85 Payer measures to drive uptake
90 Uptake of most biosimilar products in Germany has been high
92 Bibliography

93 ITALY
93 Datamonitor Healthcare insights and strategic recommendations
93 AIFA considers all biosimilar applications in Italy
93 AIFA issued a concept paper on biosimilars to clarify the legal framework around biosimilar procurement and use
94 Biosimilars in Italy are required to offer at least 20% discount on the price of their originators
94 Drivers and resistors to biosimilar use in Italy
95 The prevalent use of biosimilars in Italy is in biologic-naïve patients, but switching experienced patients onto a biosimilar also occurs
96 The key drivers to biosimilar uptake in Italy are budget constraints and guidelines encouraging the use of cheaper options
97 Certain regions set provisions to regulate biologic prescription and control expenditure
98 Bibliography

99 SPAIN
99 Datamonitor Healthcare insights and strategic recommendations
99 Biosimilars in Spain should be priced 30% lower than their branded counterpart
100 Payer measures to drive uptake
107 Bibliography

109 UK
109 Datamonitor Healthcare insights and strategic recommendations
109 The UK has a free pricing system for biosimilars
110 CCGs are responsible for a large proportion of commissioning but NHS England is the payer for biosimilars in oncology
110 Tendering and procurement in the UK is a complex process
112 Biosimilars in the UK are not viewed as interchangeable
115 Payer measures to drive biosimilar uptake in the UK
123 Biosimilar adoption has been a relative success in the UK
123 Biosimilar adoption varies depending on region and molecule
128 Bibliography

130 BIOSIMILAR DIFFERENTIATION
130 Added services are viewed as valuable by some payers
132 Availability of pre-filled infusion bags is a valuable service to UK payers
133 Product presentation and packaging may matter more than expected
134 Identity of the company matters but consistency of supply is more important

135 Bibliography

136 METHODOLOGY
136 Primary research

LIST OF FIGURES
75 Figure 1: Drivers and resistors to biosimilar use in France
86 Figure 2: Drivers and resistors to biosimilar use in Germany
95 Figure 3: Drivers and resistors to biosimilar use in Italy
101 Figure 4: Drivers and resistors to biosimilar use in Spain
115 Figure 5: Drivers and resistors to biosimilar use in the UK

LIST OF TABLES
12 Table 1: List of biosimilar guidelines issued by the EMA
18 Table 2: Biosimilars with marketing authorization in the EU by the EC, following an assessment by the EMA’s CHMP, 2006–17
30 Table 3: EMA definitions of biosimilar interchangeability, substitution, and switching
31 Table 4: Overview of the general opinions on automatic substitution and switching in the five major EU markets
32 Table 5: Position statements on automatic substitution and switching: EU-wide organizations
34 Table 6: Position statements on automatic substitution and switching in the UK
38 Table 7: Position statements on automatic substitution and switching in Germany
40 Table 8: Position statements on automatic substitution and switching in France
41 Table 9: Position statements on automatic substitution and switching in Italy
44 Table 10: Position statements on automatic substitution and switching in Spain
47 Table 11: Biosimilar market access overview in the five major EU markets
74 Table 12: ASMR ratings and pricing implications