Biosimilar Drugs in Europe: threat or opportunity to innovation?

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Biosimilar Drugs in Europe threat or
opportunity to innovation?Market Research
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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 OverviewIn 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 featuresDiscussion 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 BenefitsAccess 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

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• Key Questions AskedWhat are the key issues
  KOLs raise regarding their relationship with
  industry?What changes do KOLs want to see in
  regards to issues like digital media and the
  requirements of oncologists?How KOLs see their
  role in trial design and post-trial feedback?
• Who Would Benefit From This Report?Medical and
  scientific affairs managersClinical trial
  executivesKey account and territory
  managersMarketing, brand and sales
  managersMedical science liaisonsBusiness
  development executivesRegulatory and government
  affairs professionals
• Key quotes'When I send my juniors to a meeting
  in the US, they don't get the credit. Likewise,
  people from the US attend European meetings but
  they don't get any reward. The systems are not
  talking to each other. Pharma should assist us in
  developing a much better deal, which looks at the
  needs from both windows.' Professor Riccardo
  Audisio, M.D., Consultant Surgical Oncologist -
  St Helens Teaching Hospital, St Helens, UK'You
  are greeted by completely new people, who have
  new ideas, and then you have to start over. It's
  frustrating having new people all the time and
  having nobody pay attention.' Professor Paul
  Bunn, MD, Professor of medicine (medical
  oncology), head of the division of medical
  oncology, University of Colorado, Denver'The
  one change I would like to see is to have the
  companies be more disease-specific develop teams
  that are around a disease process rather than
  around a drug.' KOL from the University of
  Pittsburgh, US'Advisory board meetings often
  arrive at a number of good suggestions, but
  there's never any follow-up. You have a really
  experienced group of clinicians in the middle of
  a heated discussion, and then a year or two years
  goes by, and what really came out of it? So some
  sort of feedback mechanism, I think, would be a
  beneficial addition to the current model.'
  Professor Oliver Sartor, Medical Director of the
  Tulane Cancer Center, Tulane University, New
  Orleans

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Key Questions AskedWhat 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
ReportMarket 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
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Expert ViewsCarsten 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 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." "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." 
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• Variations can cause issues with
  immunogenicityThe 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 biosimilarsThe defensive
  position Originator companies will try to limit
  biosimilar uptakeLifecycle 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 shareProtecting the
  market through degree of similarity - is a
  biosimilar really similar? Competitive pricing
  and rebate agreements will keep cost-sensitive
  customersThe offensive position breaking into a
  new marketPricing is the key differentiator for
  biosimilars Knowing the market will help gain
  market share

• Content HighlightsExecutive summaryBiosimilar
  drugs in EuropeWhat are biosimilars?Generics
  and biosimilars - similarities and
  differences Biosimilars available so far in
  EuropeThe market opportunities for biosimilars
  in EuropeThe 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 typeBiosimilar uptake
  will vary by molecule and indication across
  Europe Epoetin uptake may have been slowed by
  immunogenicity issues Filgrastim uptake has been
  faster in EuropeBiosimilar 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
  biosimilarsThe challenges for biosimilars in
  EuropeThe 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 

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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 physiciansGaining market share by adding
value Devices and formulations Making the
biosimilar easier to use Devices Making the
biosimilar easier to handle formulations Protect
ing biosimilars through patentsThe company
landscape Opportunities for companies in
biosimilarsGenerics companies will be key
playersCollaboration and licensing in the
biosimilars marketCollaborations between
generics companies - bringing together
development and marketing Collaborations between
generic and originator companies combines
know-how and manufacturing capabilities Geographi
c 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 indicationBiosimilar
deals Deal case studies Biopharma company signs
agreement to access biosimilars Generics company
signs agreement to fill pipelineWhat'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 approvalThe US Changing the
biosimilars environmentConclusionAcknowledgement
sBibliography
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