DUBLIN, Feb. 15, 2018 /PRNewswire/ --

The "Biosimilars Market Access in the EU" report has been added to ResearchAndMarkets.com's offering.

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.

Key Topics Covered:

EXECUTIVE SUMMARY

• A 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-nave 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

For more information about this report visit https://www.researchandmarkets.com/research/qjf9d6/2018_biosimilars?w=5

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