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Biosimilar drugs in europe


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Biosimilar drugs in europe

  1. 1. Biosimilar Drugs in Europe: threat or opportunity to innovation? 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 modificationAbstractBetween now and 2019, a vast range of blockbuster drugs will go off patent, opening the floodgates inthe EU to the biosimilars market. Already established there since 2006, biosimilars are set to be worthbetween $2.25 billion and $4.8 billion by 2015.The potential is undeniable. Yet even in its advanced state compared to other regulated and unregulatedmarkets, European biosimilars continue to be challenged by issues and hurdles, ranging fromdevelopment and manufacturing to approval and opposition from originator companies. What lessonsare there to be learned?Report Overview
  2. 2. In Biosimilar Drugs in Europe: Threat or Opportunity to Innovation?, FirstWord Dossier examines theemerging biosimilars market. The report, based on expert interviews and analysis, examines marketdifferences across Europe and different therapeutic areas. The impact of biosimilars on originatorcompanies - and their response - is discussed, as well as strategies biosimilar companies will engage in toexpand their market share. And most importantly, the report offers insight into biosimilar deals and whatthe future holds in the EU.Key featuresDiscussion of biosimilar markets in five geographic areasExamination of key factors driving biosimilar uptake, including molecule and indicationsDetailed overview of development, manufacturing and approval issues in EuropeInsight into the position and protectionism of originator companiesReporting on the role of collaborationKey BenefitsAccess to firsthand opinions from experts in the biosimilars and biotechnology industryReview of deal-making data in biosimilars from a deal-making market leaderForward-looking analysis of the future of biosimilarsKey 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?Whats next for biosimilars?Who Should Read This ReportMarket access directors and managersMedical and scientific affairs professionalsPricing and reimbursement teamsIntellectual property professionalsPatent analystsLegal affairs teamsRegulatory and government affairs professionalsExpert ViewsCarsten Thiel, Regional Vice President, Europe and Australia, AmgenPaul Greenland, EMEA Director of Biosimilars and Proprietary Marketing at HospiraDuncan Emerton, Head of Biosimilars, Datamonitor Healthcare ConsultingAsa Cox, Founder of biosimilarlicensing.comLee Coney, Chief Scientific Officer, Biologics, Huntingdon Life SciencesJim Furniss, Director, Global Market Access Strategy, Bridgehead InternationalAndrew Teuten, Senior Partner, Sagittarius IP
  3. 3. Key Quotes"The size of the global biologics market creates a massive opportunity for biosimilar developers to comein and take some of that market. The size of the prize in Europe will be significant, so theres a bigincentive for biosimilar companies to come in, develop these biosimilar products, and compete againstthe originator brands for market share."- Duncan Emerton, Head of Biosimilars, Datamonitor Healthcare ConsultingI cant 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 willnot match those of the small molecule drugs.""You can see that over time the biosimilar products have started to be accepted and used quite broadlyin certain markets. There is a difference in uptake between countries - the uptake of biosimilars is notuniform across all the EU - and there is a difference between individual molecules as well."Table of Contents :Content HighlightsExecutive summaryBiosimilar drugs in EuropeWhat are biosimilars?Generics and biosimilars - similarities and differencesBiosimilars available so far in EuropeThe market opportunities for biosimilars in EuropeThe biologics patent cliff will have an impact on the marketMarket types for biosimilars will differ across EuropeGeographic markets for biosimilars will vary across EuropeIn Italy, prescriptions are fulfilled by brandIn France and Spain, drugs are discounted to targetsIn the UK, biosimilar uptake is driven by NICEIn Germany, biosimilars uptake is good but varies by drug typeBiosimilar uptake will vary by molecule and indication across EuropeEpoetin uptake may have been slowed by immunogenicity issuesFilgrastim uptake has been faster in EuropeBiosimilar use is likely to vary between chronic and episodic treatmentThere may be a resistance to switching patients on established treatmentsHospital physicians may be more likely to use biosimilars than primary care physiciansBiosimilars will have an impact in cost-sensitive marketsThe paediatric population may be reluctant to take up biosimilarsThe challenges for biosimilars in EuropeThe biosimilars challenge: Gaining approval in EuropeThe EU regulatory process for biosimilarsBiosimilar regulations will be a steep learning curveWill regulations be fair and balanced on all points?The biosimilars challenge: Overcoming development and manufacturing hurdlesBiologics are highly variable by nature
  4. 4. Variations can cause issues with immunogenicityThe biosimilars challenge: Overcoming patent hurdlesThe biosimilars challenge: Gaining stakeholder trustPayers can be a major driver for biosimilars uptakePhysicians will be key gatekeepers for biologics and biosimilarsPatients may be cautious about biosimilarsThe defensive position: Originator companies will try to limit biosimilar uptakeLifecycle management can maintain market shareLack of automatic substitution will protect originator drugsExclusivity provisions and patents will protect originator drugsOriginator companies can exploit loyalty to maintain market shareFocusing on quality, safety and efficacy claims can maintain loyaltyUsing 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 biosimilarsKnowing the market will help gain market shareInformation and education: defending biosimilars against the naysayersSales, marketing and account management: Market share through talking to the payersEducation for healthcare professionals: Market share through talking to the physiciansGaining market share by adding value: Devices and formulationsMaking the biosimilar easier to use: DevicesMaking the biosimilar easier to handle: formulationsProtecting 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 marketingCollaborations between generic and originator companies combines know-how andmanufacturing capabilitiesGeographic collaborations allows access to wider marketsLooking into biosimilars deal dataBiosimilar deals by volumeBiosimilar deals by valueBiosimilar deals by typeBiosimilar deals by indicationBiosimilar deals: Deal case studiesBiopharma company signs agreement to access biosimilarsGenerics company signs agreement to fill pipelineWhats next for biosimilars in Europe?Monoclonal antibodies will be a dramatic entry to the biosimilars marketBiobetters could follow-on from biosimilarsBiobetters will follow a different route of approvalThe US: Changing the biosimilars environmentConclusion
  5. 5. AcknowledgementsBibliographyRelated Keywords : Market, Research, Report, Business, Industry, Information, Automotive,Banking, Finance, Food, Beverages, Technology, Biomass, Books, Conference, CompanyProfiles, CountryFor More details about above & other Reports plz contact :PranaliAarkstore.comContact: Marketing teamMob.No.918149852585Email: , discount@aarkstore.comURL: http://www.aarkstore.com