Between now and 2019, a vast range of blockbuster drugs will go off patent, opening the floodgates in the EU to the biosimilars market. Already established there since 2006, biosimilars are set to be worth between $2.25 billion and $4.8 billion by 2015.
The potential is undeniable. Yet even in its advanced state compared to other regulated and unregulated markets, European biosimilars continue to be challenged by issues and hurdles, ranging from development and manufacturing to approval and opposition from originator companies. What lessons are there to be learned?
Report Overview
In Biosimilar Drugs in Europe: Threat or Opportunity to Innovation?, FirstWord Dossier examines the emerging biosimilars market. The report, based on expert interviews and analysis, examines market differences across Europe and different therapeutic areas. The impact of biosimilars on originator companies—and their response—is discussed, as well as strategies biosimilar companies will engage in to expand their market share. And most importantly, the report offers insight into biosimilar deals and what the future holds in the EU.
Key features
Discussion of biosimilar markets in five geographic areas
Examination of key factors driving biosimilar uptake, including molecule and indications
Detailed overview of development, manufacturing and approval issues in Europe
Insight into the position and protectionism of originator companies
Reporting on the role of collaboration
Key Benefits
Access to firsthand opinions from experts in the biosimilars and biotechnology industry
Review of deal-making data in biosimilars from a deal-making market leader
Forward-looking analysis of the future of biosimilars
Key Questions Asked
What are the challenges facing biosimilars in Europe?
How can biosimilars companies take market share in Europe?
How can originator biologics companies keep market share in Europe?
Which companies are collaborating over biosimilars development?
What deals are being made?
What’s next for biosimilars?
Who Should Read This Report
Market access directors and managers
Medical and scientific affairs professionals
Pricing and reimbursement teams
Intellectual property professionals
Patent analysts
Legal affairs teams
Regulatory and government affairs professionals
Key quotes
“The size of the global biologics market creates a massive opportunity for biosimilar developers to come in and take some of that market. The size of the prize in Europe will be significant, so there’s a big incentive for biosimilar companies to come in, develop these biosimilar products, and compete against the originator brands for market share.”
– Duncan Emerton, Head of Biosimilars, Datamonitor Healthcare Consulting
“I can't see the biosimilars market following the classic small molecule generic model where on day one, five molecules enter the market and the price drops to 20 percent of the brand. The economics just will not match those of the small molecule drugs.”
– Asa Cox, founder of biosimilarlicensing.com
“You can see that over time the biosimilar products have started to be accepted and used quite broadly in certain markets. There is a difference in uptake between countries – the uptake of biosimilars is not uniform across all the EU – and there is a difference between individual molecules as well.”
– Paul Greenland, EMEA Director of Biosimilars and Proprietary Marketing at Hospira
Expert Views
Carsten Thiel, Regional Vice President, Europe and Australia, Amgen
Paul Greenland, EMEA Director of Biosimilars and Proprietary Marketing at Hospira
Duncan Emerton, Head of Biosimilars, Datamonitor Healthcare Consulting
Asa Cox, Founder of biosimilarlicensing.com
Lee Coney, Chief Scientific Officer, Biologics, Huntingdon Life Sciences
Jim Furniss, Director, Global Market Access Strategy, Bridgehead International
Andrew Teuten, Senior Partner, Sagittarius IP
Generic Drug Industry in Europe
Executive summary
Biosimilar drugs in Europe
What are biosimilars?
> Generics and biosimilars – similarities and differences
> Biosimilars available so far in Europe
The market opportunities for biosimilars in Europe
> The biologics patent cliff will have an impact on the market
> Market types for biosimilars will differ across Europe
> Geographic markets for biosimilars will vary across Europe
> In Italy, prescriptions are fulfilled by brand
> In France and Spain, drugs are discounted to targets
> In the UK, biosimilar uptake is driven by NICE
> In Germany, biosimilars uptake is good but varies by drug type
> Biosimilar uptake will vary by molecule and indication across Europe
> Epoetin uptake may have been slowed by immunogenicity issues
> Filgrastim uptake has been faster in Europe
> Biosimilar use is likely to vary between chronic and episodic treatment
> There may be a resistance to switching patients on established treatments
> Hospital physicians may be more likely to use biosimilars than primary care physicians
> Biosimilars will have an impact in cost-sensitive markets
> The paediatric population may be reluctant to take up biosimilars
The challenges for biosimilars in Europe
> The biosimilars challenge: Gaining approval in Europe
> The EU regulatory process for biosimilars
> Biosimilar regulations will be a steep learning curve
> Will regulations be fair and balanced on all points?
> The biosimilars challenge: Overcoming development and manufacturing hurdles
> Biologics are highly variable by nature
> Variations can cause issues with immunogenicity
> The biosimilars challenge: Overcoming patent hurdles
> The biosimilars challenge: Gaining stakeholder trust
> Payers can be a major driver for biosimilars uptake
> Physicians will be key gatekeepers for biologics and biosimilars
> Patients may be cautious about biosimilars
The defensive position: Originator companies will try to limit biosimilar uptake
> Lifecycle management can maintain market share
> Lack of automatic substitution will protect originator drugs
> Exclusivity provisions and patents will protect originator drugs
> Originator companies can exploit loyalty to maintain market share
> Focusing on quality, safety and efficacy claims can maintain loyalty
> Using marketing, sales and healthcare professional training to attract and keep market share
> Protecting the market through degree of similarity – is a biosimilar really similar?
> Competitive pricing and rebate agreements will keep cost-sensitive customers
The offensive position: breaking into a new market
> Pricing is the key differentiator for biosimilars
> Knowing the market will help gain market share
> Information and education: defending biosimilars against the naysayers
> Sales, marketing and account management: Market share through talking to the payers
> Education for healthcare professionals: Market share through talking to the physicians
> Gaining market share by adding value: Devices and formulations
> Making the biosimilar easier to use: Devices
> Making the biosimilar easier to handle: formulations
> Protecting biosimilars through patents
The company landscape: Opportunities for companies in biosimilars
> Generics companies will be key players
Collaboration and licensing in the biosimilars market
> Collaborations between generics companies – bringing together development and marketing
> Collaborations between generic and originator companies combines know-how and manufacturing capabilities
> Geographic collaborations allows access to wider markets
> Looking into biosimilars deal data
> Biosimilar deals by volume
> Biosimilar deals by value
> Biosimilar deals by type
> Biosimilar deals by indication
> Biosimilar deals: Deal case studies
> Biopharma company signs agreement to access biosimilars
> Generics company signs agreement to fill pipeline
What’s next for biosimilars in Europe?
> Monoclonal antibodies will be a dramatic entry to the biosimilars market
> Biobetters could ‘follow-on’ from biosimilars
> Biobetters will follow a different route of approval
> The US: Changing the biosimilars environment
Conclusion
Acknowledgements
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