Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

Gauging the biosimilar effect


Published on

Aarkstore announce a new report "" through its vast collection of market research report.

  • Be the first to comment

  • Be the first to like this

Gauging the biosimilar effect

  1. 1. Aarkstore: Gauging the Biosimilar Effect Report Links: FirstImpact: FDA approval of Aubagio Consensus Outlook: Multiple Sclerosis Therapy Trends: Multiple Sclerosis -- KOL Insight and Consensus Outlook Modules Pharmas Future Role in CME Therapy Trends: Rheumatoid Arthritis -- Consensus Outlook Module Therapy Trends: Rheumatoid Arthritis -- KOL Insight and Consensus Outlook Modules Therapy Trends: Rheumatoid Arthritis -- KOL Insight Module Pharma Reputations: Managing Perceptions Pharma sales force shape, size and structure — where next? Sampling: A key business driver in a multi-channel environment Inside China’s Healthcare Reforms: Opportunities for Multinational Pharma Effective Sales and Marketing Strategies for Orphan Drugs New Product Penetration: Understanding & Accelerating New Product Uptake Managing Investigator Initiated Research Therapy Trends: Alzheimers Disease - Breaking new ground in disease modification Therapy Trends: Multiple Sclerosis Branded Generics in South East Asia: Current and Future Opportunities Market Access: Communicating Value Stories to PayersIt was supposed to be the “epoch of biosimilars”, or drugs that copied existing biologics but had thepotential to be more cost-effective. Yet five years later, biosimilars have failed to reach their forecastedpotential of $16.4 billion in sales this year, falling short to just $235 million in 2010. The pitfalls—everything from cost and unfavorable US legislation to a lack of interchangeability and physicianresistance—have led some in the industry to ring the death knell. Yet according to others, the marketremains alluring, predominantly because it represents life-changing medicine and the future ofhealthcare. Report Overview Cast against European and particularly German experiences, Gauging theBiosimilar Effect: will the market boom or bust? looks at the current state-of-play for biosimilars. The
  2. 2. report, based on 16 industry interviews, examines the drivers and resistors to the still-unprovenbiosimilars market. The report moves from a general discussion of biosimilars to an explanation why theyproved immediately popular in Germany. Market drivers—patent expiry, developing markets and costssavings—are reflected against the roadblocks, including high barriers to entry, lack of substitution,repressive US legislation and the physicians’ reluctance to engage. Finally, the report reviews theresponses of both innovator and biosimilar companies, as well as their strategies for future success. KeyReport Features Comprehensive and up-to-date overview of the biosimilars market Insight into theresistors and drivers to biosimilar uptake Strategies on how to improve biosimilar spending Discussion ofhow the branded industry should respond to defend market share Key Benefits Insight from 16 industryleaders from Europe, the US and Canada Unique insight into the German biosimilars marketRecommendations of how the industry can move forward Key Questions Asked What are the drivers andresistors of biosimilar uptake? Why was Germany the most successful market for biosimilars Whatstrategies should biosimilar manufacturers do to increase uptake How should the branded industryrespond? How will the biosimilars industry evolve and what forces will shape it Who Would Benefit FromThis Report? Executive Management Sales and Marketing Executives Pricing and Reimbursement TeamsMedical and Scientific Affairs Professionals Pharmaceutical Consultants Strategic Planning ExecutivesClinical Development Professionals Regulatory and Government Affairs Managers Key quotes “I thinkthat the biosimilar market will become a part of the landscape where major pharmaceutical companiesand biotechnology companies will control that market, and use the biosimilar market as a means toextend the lifecycle of their innovative franchises.” – Clifford Mintz, Management Consultant “In the USand other countries where there is much more importance placed on price, and where the private sectorinsurers are a lot more involved, and where government is now seeking to reduce drug spending, yes,price could very well be the number one determinant of gaining market share for biosimilars in the USmarket.” – Ronald Rader, President of the Biotechnology Information Institute “Unless you have 100%patient interchangeability, you don’t have 100% medication interchangeability. You have acceptableranges. But an acceptable range for a generic statin is one thing. An acceptable interchangeability ratefor rheumatoid arthritis is something else entirely.” – Peter Pitts, President and Cofounder, Center forMedicine in the Public Interest Expert Views Gillian Woollett, Vice President, Avalere Health Louis-Christian Clauss, Senior Consultant, Hisut SA and Atheln Biomed Peter Pitts, President and Cofounder,Center for Medicine in the Public Interest Markus Hauser, Director Strategic Commercial Effectiveness,Biogen Idec Alex Kanarek, Senior Consultant, BioProcess Technology Consultants Inc. Sandy Eisen, ChiefMedical Officer, Frontline Pharma Consulting Andrew Bourgoin, Pharmaceutical Research Analyst,Thomson Reuters Andrew Merron, Director, Biosimilars Advisory Service & Oncology, Decision ResourcesRonald Rader, President, Biotechnology Information Institute Steven Grossman, Consultant, Public Policyand FDA Magdalena Leszczyniecka, Founder and CEO, STC Biologics Inc. Kristie Kuhl, Senior VicePresident, Makovsky & Co. Clifford Mintz, Management Consultant Dimitrios Papadopoulos, CommercialExecutive in the Pharmaceutical Industry Regina Au, Strategic Marketing Consultant, BioMarketingInsight Michael Castagna, Executive Director, Immunoscience Division, Bristol-Myers Squibb.Table of Contents :Executive SummaryBiologicsThe Biologics MarketPatent Landscape
  3. 3. Innovation comes at a costBiosimilarsTerminologyRegulatory OverviewThe Biosimilars MarketThis is not a generics marketEU’s biosimilars marketBiosimilar uptake in the EUInitial uptake was rapid in GermanyReference Pricing SystemReimbursement systemPre-defined quotasMarket Drivers and ResistorsMarket DriversCost savingsPatent expiryFierce competitionGrowth of developing marketsExpanding uses of drugsMarket ResistorsHigh barriers to entryCostTechnical challengesClinical challengesLack of substitution and interchangeabilitySubstitutionInterchangeabilityWholesale switchingTherapeutic substitutionUnfavorable biosimilars laws in the USPeriod of market exclusivityData sharingReluctant physiciansSwitchingLack of physician and patient educationOutright opposition to biosimilarsLack of incentivesPatient and public misperceptionAssignment of the International Nonproprietary Name (INN)Response from innovator companiesReduce the price of the innovator drugForm a biosimilars divisionPartner with a biosimilars companyRely on their resources
  4. 4. Develop innovative second-generation drugsResponse from biosimilars companiesMake a capital investmentDevelop competitive marketing strategiesEarly entry strategiesDirect marketingEmerging marketsChoice of targetForm partnershipsHave a legal strategy in placeMarket outlookSummaryAcknowledgementsRelated Keywords: Market forecasts, Market analysis, Marketing report, Company reports, Company,Profiles, CompanyInformation, Country,reports