What is the future for biosimilars in the EU?
What issues do EU Payers think will impact adoption, pricing and reimbursement of biosimilars?
In January 2016 Samsung Bioepis launched Benepali, a biosimilar version of Enbrel marking a significant advance in biosimilar therapy options. With biosimilar versions of Avastin and Herceptin in the pipeline, the sector is on the verge of delivering lower cost yet equally effective medicines. Payers are enthusiastic about the savings biosimilars bring but warn that physician fear, stoked by a lack of data, clinical inexperience and misinformation, is limiting biosimilar uptake. As the market matures, expect wider clinical adoption and patient support, though questions around price discounting and substitution remain unresolved.
In-depth interviews reveal unique and frank insights from 15 national and regional payers in Germany, France, Italy, Spain and the UK
Table summarising existing biosimilar approvals and current regulatory pipeline to the EMA
At-a-glance summaries of all the key insights
Understand how the biosimilar market has grown in 2016 and what are the stand out developments
Investigate national trends driving adoption, pricing and reimbursement of biosimilars.
Examine how biosimilar cost savings are being reinvested in health and the positive impact this is having on payer perceptions
Gain insight into the role of patient groups whose voice is becoming increasingly heard in biosimilars discussions
Assess the current climate for price discounting and why a uniform price reduction is unlikely among EU member states
Review the ongoing arguments for switching from originator to biosimilar products and learn how they differ at the national level
Create communication strategies that challenge misinformation and instil confidence in clinicians and patients
Key Questions Answered By This Report
Market movements: What biosimilar products were approved in 2016 and which companies have been most active?
Discounts: 25%, 50% 70% – payers want significant discounts for biosimilars, but what is the right level and should it be available to everyone?
Switching: What are the national obstacles to switching from a brand to a biosimilar, and is there a role for developers in bringing about change?
Fear factor: Clinician and patient fear is limiting biosimilar adoption. Education can help, but who should be responsible for its creation and can industry have a role?
Misinformation: What can biosimilar developers do to defend their products from originator misinformation about the safety and efficacy of biosimilar products?
Italian job: What market and regulatory developments make Italy a biosimilar market to watch for biosimilar companies?
To ensure candid views were expressed, the names of payers have been kept anonymous. Each contributor has been carefully selected for their experience and detailed knowledge of the national and regional biosimilar market and their insights provide a unique front line perspective for industry.
United Kingdom Payers:
West Hampshire CCG
CHU AP-HP Garches
Statutory Health Insurance (SHI)
Regional Payer: Valencia
Regional Payer: Basque County
Regional Payer: Cataluna
National Payer: Piedmont
Regional Payer: Sicily
Regional Payer: Emilia-Romagna
4 Key Quotes
“Obviously biosimilars are giving us significant cost savings because they are cheaper than the originator molecules with all the same indications. So certainly in my area, we are very pro biosimilars. But for us locally, the reason that we’ve been able to switch [to biosimilars] is because we’ve shared savings with secondary care commissions. It’s allowed us to develop the service and the feedback from patients is actually that it’s better than it was before because they’ve got more time, they are being monitored more closely and they just feel there are getting more out of the service than they were when they were on a branded product, indirectly, because we have invested the money back into the service.”UK Payer
“It is my personal thinking that it would be better to have the possibility to distinguish [between originator biologics and biosimilars]. I do not understand why having another non-proprietary name is a problem. We have this already with several substances. So of course, it’s not really a problem and they can do this in my opinion. It will improve the safety.”German Payer
“Formulary inclusion has been quite quick, once the product has been authorised. In fact, I think it has accelerated a bit and it will be accelerated in the future too because the market is growing. So at the regulatory level, AIFA and EMA, they have accepted this market, which they looked at with misgivings before. The process has accelerated, because all the verification processes are streamlined.” Italian Payer
“At this time it should be [the choice of physicians]. We need perhaps one or two more years to ensure that we don’t have a problem with safety, that we don’t have a problem in immunogenicity, for example. But after that, I think the pharmacists should be aware and should be able to switch like the generics.” French Payer
Who Would Benefit from This Report?
Commercial teams negotiating biosimilar prices and discounts with payers
Marketing teams communicating the benefits and safety of biosimilars
Medical affairs teams building the evidence case for biosimilars with physicians and payers
MSL teams engaging with physicians about biosimilar safety and efficacy
Market research and HEOR teams analysing long-term real world data on biosimilar use and outcomes
Biosimilars in Europe: Where we currently stand
Biosimilar approvals in Europe to date
Uptake and usage of biosimilars in Europe
Awareness and perceptions of biosimilars
New biosimilar approvals, increased regulatory clarity, push for cost savings top changes over past 12 months
Promoting cost-savings remains most prominent way for countries to boost biosimilar use
Physicians remain key driver in biosimilar adoption; patient groups growing increasingly vocal
Complexity of biosimilars remains key barrier to uptake; manufacturer information also an issue
KOLs remain unsure who should head up biosimilar education efforts
Approval of Benepali viewed as turning point for biosimilar awareness
KOLs supportive of current regulatory oversight, but need greater guidance on switching
Regulations satisfactory for formulary decisions, particularly in indication extrapolation
Increased insight into manufacturing process, real world data could bolster confidence in market
Recent regulatory changes to further define biosimilars welcomed by KOLs
EC orphan drug legislation isn’t expected to have significant impact
Biosimilar approval, use and tracking:
Current naming policies falling short of KOL expectations
Non-inferiority should be sufficient grounds for regulatory approval, except for indication extrapolation
Acceptance of indication extrapolation continues, but is siloed by specialty
KOLs remain generally positive about interchangeability
Switching permissible in treatment naïve patients; existing patients represent a new growth area
Pharmacy-level substitution remains a hot button issue, but option may be on the horizon
Education key to switching support, but KOLs unsure of who should provide data
Physician fears, market turbulence and originator company misinformation remain barriers
EMA has significant role to play in biosimilar adoption, but may not be best for general oversight
Physicians should have final say on interchangeability for now, but times could be changing
Cost savings remain primary driver of biosimilar appeal
Fuelled by progress in Scandanavian countries, KOLs push for deeper discounts
Discounts in select EU markets could become replicable in near future
Scandanavian countries leading the way in biosimilar uptake, but select EU states gaining ground
Price-matching biosimilars to originator therapies remains unlikely
Future challenges/opportunities for biosimilars in Europe
Lack of guidance on switching remains primary barrier to greater biosimilar adoption
Potential for cost savings remains greatest opportunity for biosimilars
EU no closer to accepting biosimilars as ‘generic’ versions of reference products
Physicians remain most influential on future acceptance, but other stakeholders cannot be ignored
Opportunity to learn from US limited, as market dynamics too dissimilar to EU
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Table of Contents
for Biosimilars: European Payer Perspectives
2.Research objectives and methodology
3.Biosimilars in Europe: Where we currently stand
3.1 Biosimilar approvals in Europe to date
3.2 Uptake and usage of biosimilars in Europe
4. Awareness and perceptions of Biosimilars
4.1 Key Insights
4.2 New biosimilar approvals boosts acceptance over past 12 months
4.3 Promoting cost savings key to boosting biosimilar use
4.4 Physicians remain key driver in biosimilar adoption, although patient groups growing increasingly vocal
4.5 Complexity of biosimilars remains key barrier, but manufacturer misinformation also an issue
4.6 Payers remain unsure who should head up biosimilar education efforts
5. Regulatory environment
5.1 Key insights
5.2 Payers need greater guidance on switching
5.3 Regulations satisfactory for formulary decisions, particularly for indication extrapolation
5.4 Current guidance on biosimilarity ambiguous, but reflects nature of biological medicines
5.5 Increased insight into manufacturing processes, real-world data could boost uptake
5.6 Guidance to further define biosimilars welcomed by payers
5.7 EC biosimilar legislation not expected to have significant impact
5.8 Time for approval process to be expedited, payers suggest
6. Biosimilar approval, use and tracking
6.1 Key insights
6.2 Current naming policies falling short of payer expectations
6.3 Utility of naming strategies questioned, may promote compartmentalisation
6.4 Non-inferiority should be sufficient for approval
6.5 Acceptance of indication extrapolation growing, but is siloed by specialty
6.6 Payers remain generally positive about interchangeability 46
6.7 Switching permissible in treatment-naïve patients, but existing patients represent growth area
6.8 Pharmacy-level substitution remains a hot button issue
6.9 Education key to switching support, but payers unsure of who should provide data
6.10 Physician fears, market turbulence and misinformation impede biosimilar acceptance
6.11 Market location, clinical experience fuel biosimilar bias
6.12 EMA has significant role in biosimilar adoption, but oversight may be limited
6.13 Physicians should have final say on interchangeability for now
7.1 Key insights
7.2 Formulary decision-making process largely unchanged versus last year
7.3 Cost savings remain primary driver of biosimilar appeal
7.4 Fuelled by progress in Scandinavian countries, payers push for deeper discounts
7.5 Discounts in select EU markets could become replicable in near future
7.6 Select EU states gaining ground in biosimilar uptake
7.7 Price-matching biosimilars to originator therapies remains unlikely
7.8 Increased prescription monitoring potentially a precursor to prescribing targets and penalties
8. Future challenges/opportunities for biosimilars in Europe
8.1 Key insights
8.2 Lack of guidance on switching remains significant barrier to greater biosimilar adoption
8.3 Potential for cost savings remains greatest opportunity for biosimilars
8.4 EU no closer to accepting biosimilars as ‘generic’ versions of reference products
8.5 Physicians remain most influential on future acceptance, but other stakeholders emerging
8.6 Critical Success Factors remain relevant, although priorities are shifting
8.7 Opportunity to learn from US limited as market dynamics too dissimilar to EU
9.2 Experts interviewed for this report
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