Biosimilar Drugs in Europe: Threat or Opportunity to Innovation?

Date: November 23, 2011
Pages: 47
Price:
US$ 595.00
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Publisher: FirstWord
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: B2F1E563672EN
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Biosimilar Drugs in Europe: Threat or Opportunity to Innovation?
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
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

BIBLIOGRAPHY
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