Reportsn reports – multi therapy drugs opportunities for generics & biosimilars

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Reportsn reports – multi therapy drugs opportunities for generics & biosimilars

  1. 1. Multi-therapy Drugs: Opportunities for Generics & BiosimilarsReportsnReports.com adds Espicom Limited Market Research Report “Multi-therapy Drugs:Opportunities for Generics & Biosimilars’’ to its store.Targeting multiple conditions is likely to increase a drug’s potential target audience andresult in large financial returns for the developing company. With annual sales counted inbillions of dollars, these blockbuster drugs are undoubtedly attractive to companiesdeveloping generics and biosimilars.The logic is simple: more indications result in a larger number of potential patients and,consequently, greater revenue opportunities. Obviously this logic only works if there isunmet clinical need and efficacy is demonstrated in each indication, so the number of drugsapproved for multiple indications is relatively small. But where multiple indications areapproved, annual sales can be counted in billions of dollars. The trend for developingproducts for multiple indications has been particularly evident in biological pharmaceuticalsand has resulted in multi-billion dollar sales over a number of years. The commercial costsof developing biosimilars are great. Better, then to have the possibility of multiple revenuestreams.Use this new report to easily answer key business questions, such as: What is the latest position on extrapolating biosimilar approvals to other indications, and what impact could this have on the sector? How is Big Pharma’s attitude changing as the biosimilar market develops? Remicade (infliximab) generated sales of US$7.9 billion in 2010 and is indicated for 7 conditions –what are they? Which companies are known to be developing biosimilar versions of Pfizer/Takeda’s Enbrel (etanercept)? How might new branded development in the multi-kinase sector affect the biosimilar development of Bayer’s Nexavar (sorafenib)? What revenue generating lifecycle developments will offset the challenge of generic competition for Roche’s Xeloda (capecitabine)? Assessing additional sales potential from a valuable product fitThe multi-therapy drugs market included in this report realised total sales in excess ofUS$70 billion in 2010. It is, therefore, hardly surprising that many are being targeted bygeneric companies for the development of either traditional bioequivalent generics, or astargets for the nextwave of biosimilars.The top selling multi-therapy drug in 2010 was Enbrel (etanercept), with sales reportedseparately by Amgen, Pfizer and Takeda amounting to a total of US$7,850 million.Remicade (infliximab) was a close second, with sales reported by Johnson & Johnson andMerck & Co totalling US$7,581 million in 2010. In third place was Abbott’s Humira
  2. 2. (adalimumab), with sales of US$6,738 million; while Roche reported global sales ofRituxan/MabThera (rituximab) worth US$6,094 million in 2010.While the top five in terms of sales in 2010 were biologicals, a number of small moleculemulti-therapy drugs have established a place among the market leaders and are worthy ofattention as they will not face the same regulatory obstacles of biosimilars. These includeAstraZeneca’s Seroquel franchise, with revenue of US$5,302 million; Otsuka/Bristol-MyersSquibb’s Abilify (aripiprazole) with sales reported by Otsuka amounting to US$4,266 million;and Novartis’ Glivec/Gleevec (imatinib) with sales of US$4,265 million.Generic and biosimilar opportunities: high risk, high reward?With annual sales counted in billions of dollars, these blockbuster drugs are undoubtedlyattractive to companies developing generics and biosimilars. Competition is often fierce forbioequivalent generics of the big sellers. Consequently, companies are likely to be vying fora relatively small slice of the market. Nonetheless, when branded sales are counted inbillions of dollars, companies could still make a significant return even with generic priceerosion.The market for biosimilars is inherently different to the traditional generics market. Marketacceptance remains a big challenge and the take up of biosimilars in Europe to date hasbeen relatively slow. Not only will companies need to convince healthcare providers thatbiosimilar drugs are as good as the originator products, they will also have to compete withthe originator companies who are less likely to exit the market than if faced with a flood ofbioequivalent generics.Biosimilar approval for multiple indications: extrapolation or additional trials?One question that has yet to be fully answered with regard to multi-therapy drugs iswhether biosimilar approval for one indication will automatically lead to approval for allindications associated with the reference product.In the EU – so often the leading player in biosimilar regulation – the current position seemsa little vague. In November 2010, the EMA discussed extrapolation in its draft guideline onsimilar medicinal products containing monoclonal antibodies (MAbs:EMA/CHMP/BMWP/403543/2010). The guideline suggested the possibility of extrapolation ofclinical efficacy and safety data to other indications of the reference MAb, based on theoverall evidence of biosimilarity. However, the reality is unlikely to be simple, particularlywhen the reference product is approved in unrelated indications.The final guideline has yet to be published and a year later the subject of extrapolationremains a major topic of discussion. In the meantime, companies are hedging their bets andconducting comparative studies of their biosimilar MAbs in more than one indication.About the AuthorThe report has been researched and written by Espicom Senior Analyst, Karen Holmes.Karen has over 15 years pharmaceutical and healthcare market analysis experience. Herrecent studies includeHospital Injectable Drugs: Future Prospects for Generics and BiosimilarsEmerging Opportunities in Inhalation and Nasal Spray Generic DrugsOphthalmology Drug Futures.
  3. 3. Table Of ContentsFOREWORD . 1EXECUTIVE SUMMARY 3OVERVIEW . 5Lifecycle Development and New Indications . 5Realising Additional Sales Potential 7Rituximab: Multiple Indications from Oncology to Immunology . 8Sildenafil: One Active Ingredient, Two Distinctly Branded Indications . 9Generic and Biosimilar Opportunities . 9Biosimilar Approval for Multiple Indications: Extrapolation or Additional Trials? . 10US Patent Expiries 11PRODUCT ANALYSIS . 12ANTI-METABOLITES . 13Alimta (pemetrexed) 13Mode of Action 13Approvals 13Lifecycle Development 14Competition within the Marketplace 14Patents . 15Generic Company Activity 15Market Outlook . 15Xeloda (capecitabine) 17Mode of Action 17Approvals 17Lifecycle Development 19Competition within the Marketplace 19Colorectal Cancer 19Breast Cancer .19Gastric Cancer 20Patents . 20Generic Company Activity 20Market Outlook . 20MONOCLONAL ANTIBODIES 22Rituxan/MabThera (rituximab) . 22Mode of Action 22Approvals 22Lifecycle Development 24Competition within the Marketplace 24Patents . 24Biosimilar Activity 24Market Outlook . 25Herceptin (trastuzumab) 27Mode of Action . 27Approvals 27Lifecycle Development 28Competition within the Marketplace . 28Breast Cancer . 28
  4. 4. Gastric Cancer . 29Patents . 29Biosimilar Activity 29Market Outlook . 30Erbitux (cetuximab) 32Mode of Action . 32Approvals 32Lifecycle Development 32Competition within the Marketplace . 33Patents . 33Biosimilar Activity 33Market Outlook . 33Avastin (bevacizumab) 35Mode of Action . 35Approvals 35Lifecycle Development 36Competition within the Marketplace . 37Patents . 37Biosimilar Potential . 37Market Outlook . 37PROTEIN KINASE INHIBITORS . 39Glivec (imatinib) . 39Mode of Action . 39Approvals 39Lifecycle Development 40Competition within the Marketplace . 41Patents . 41Generic Company Activity 41Market Outlook . 42Tarceva (erlotinib) . 43Mode of Action . 43Approvals 43Lifecycle Development 44Competition within the Marketplace 44Patents . 44Generic Company Activity 45Market Outlook . 45Sutent (sunitinib) . 47Mode of Action 47Approvals 47Lifecycle Development 47Competition within the Marketplace 48Patents . 48Generic Company Activity 48Market Outlook . 49Nexavar (sorafenib) . 50Mode of Action 50Approvals 50Lifecycle Development 51
  5. 5. Competition within the Marketplace 51Patents . 51Generic Company Activity 51Market Outlook . 52OTHER ANTINEOPLASTIC AGENTS . 53Velcade (bortezomib) 53Mode of Action 53Approvals 53Lifecycle Development 54Competition within the Marketplace 54Patents . 54Generic Company Activity 55Market Outlook . 55IMMUNOSUPPRESSANTS . 57Enbrel (etanercept) . 58Mode of Action 58Approvals 59Competition within the Marketplace 60Patents . 60Biosimilar Activity . 60Merck & Co 60Avesthagen .61Protalix BioTherapeutics 61Simcere 61Market Outlook . 61Remicade (infliximab) 63Mode of Action . 63Approvals 63Competition within the Marketplace . 64Patents . 64Biosimilar Activity 65Market Outlook . 65Humira (adalimumab) . 67Mode of Action . 67Approvals 67Competition within the Marketplace . 68Patents . 68Biosimilar Activity 68Market Outlook . 69Cimzia (certolizumab pegol) . 70Mode of Action . 70Approvals 70Lifecycle Development 71Competition within the Marketplace . 71Patents . 71Biosimilar Potential . 71Market Outlook . 72Actemra (tocilizumab) . 73Mode of Action . 73
  6. 6. Approvals 73Lifecycle Development 74Competition within the Marketplace . 74Biosimilar Potential . 74Market Outlook . 74Afinitor/Zortress (everolimus) . 76Mode of Action . 76Approvals 76Lifecycle Development 77Competition within the Marketplace . 77Renal Cell Carcinoma . 77Breast Cancer . 77Patents . 78Generic Company Activity 78Market Outlook . 78Tysabri (natalizumab) 80Mode of Action 80Approvals 80Lifecycle Development 81Competition within the Marketplace 81Patents . 81Market Outlook . 81NERVOUS SYSTEM 83Lyrica (pregabalin) 84Mode of Action 84Approvals 84Lifecycle Development 84Competition within the Marketplace 85Patents . 85Generic Company Activity 85Market Outlook . 86Seroquel (quetiapine) 87Mode of Action 87Approvals 87Lifecycle Development 88Competition within the Marketplace 88Patents . 89Generic Company Activity 89Seroquel XR .89Seroquel IR 90Market Outlook . 90Abilify (aripiprazole) . 92Mode of Action 92Approvals 92Lifecycle Development 93Competition within the Marketplace 93Patents . 93Generic Company Activity 94Market Outlook . 94
  7. 7. Cymbalta (duloxetine) . 96Mode of Action 96Approvals 96Lifecycle Development 97Competition within the Marketplace 97Patents . 97Generic Company Activity 98Market Outlook . 98OTHER 100Viagra & Revatio (sildenafil) . 100Mode of Action . 100Approvals 100Lifecycle Development 100Competition within the Marketplace . 101Patents . 101Generic Company Activity 101Market Outlook . 102SOURCES . 104Espicom Sources 104Others 104DIRECTORY . 105Regulators. 105Manufacturers . 105INDEX 107List of TablesSummary of Drugs and Indications 5Drug Sales, 2010 (US$ Million) 8Drugs by US Patent Expiry 11Alimta US Patents 15Tentative ANDA Approval for Pemetrexed 15Alimta Sales 2009-2016 (US$ Million) . 16Xeloda US Patents 20Xeloda Sales, 2009-2016 (SFr & US$ Million) 21Rituxan/MabThera Sales, 2009-2016 (CHF & US$ Million) . 25Herceptin US Patents 29Herceptin Sales, 2009-2016 (CHF & US$ Million) 30Erbitux Sales by Company, 2009-2016 (EUR & US$ Million) . 34Avastin Sales by Company, 2009-2016 38Glivec US Patents . 41Glivec/Gleevec Sales, 2009-2016 (US$ Million) . 42Tarceva US Patents 45Tarceva Sales, 2009-2016 (SFr & US$ Million) 46Product US Patents 48Sutent Sales, 2009-2016 (US$ Million) . 49Product US Patents 51Nexavar Sales, 2009-2016 (EUR & US$ Million) 52Velcade US Patents 55Velcade Sales by Company, 2009-2016 (US$ Million) . 56Enbrel US Patents . 60
  8. 8. Enbrel Sales by Company, 2009-2016 (US$ Million) 62Remicade US Patents 64Remicade Sales by Company, 2009-2016 (US$ Million) . 65Humira US Patents . 68Humira Sales by Company, 2009-2016 (US$ Million) 69Cimzia Sales, 2009-2016 (US$ Million) . 72Actemra/RoActemra Sales by Company, 2009-2016 75Afinitor/Zortress US Patents . 78Afinitor/Zortress Sales, 2009-2016 (US$ Million) 78Tysabri Sales by Company, 2009-2016 (US$ Million) 81Lyrica US Patents 85FDA Tentative ANDA Approvals for Pregabalin 85Lyrica Sales, 2009-2016 (US$ Million) . 86Seroquel US Patents 89FDA Tentative ANDA Approvals for Quetiapine XR . 90FDA Tentative ANDA Approvals for Quetiapine IR 90Seroquel Sales, 2009-2016 (US$ Million) . 91Abilify US Patents . 93Abilify Sales by Company, 2009-2016 (¥ Billion & US$ Million) . 94Cymbalta US Patents . 97FDA Tentative ANDA Approvals for Duloxetine . 98Cymbalta Sales, 2009-2016 (US$ Million) 99Viagra & Revatio US Patents . 101EU Marketing Authorisations for Generic Sildenafil 102FDA Tentative ANDA Approvals for Sildenafil . 102Viagra/Revatio Sales, 2009-2016 (US$ Million) 103List of FiguresAlimta Sales Trend 2007-2016 . 16Xeloda Sales Trend, 2007-2016 . 21Rituxan/MabThera Sales Trend, 2007-2016 . 26Herceptin Sales Trend, 2007-2016 . 31Erbitux Sales Trend, 2007-2016 . 34Avastin Sales Trend, 2007-2016 38Glivec/Gleevec Sales Trend, 2007-2016 . 42Tarceva Sales Trend, 2007-2016 46Sutent Sales Trend, 2007-2016 49Nexavar Sales Trend, 2007-2016 . 52Velcade Sales Trend, 2007-2016 . 56Enbrel Sales Trend, 2007-2016 62Remicade Sales Trend, 2007-2016 66Humira Sales Trend, 2007-2016 69Cimzia Sales Trend, 2008-2016 72Actemra/RoActemra Sales Trend, 2008-2016 75Afinitor/Zortress Sales Trend, 2009-2016 . 79Tysabri Sales Trend, 2007-2016 . 82Lyrica Sales Trend, 2007-2016 86Seroquel Sales Trend, 2007-2016 . 91BMS Abilify Sales Trend, 2007-2016 95Otsuka Abilify Sales Trend, 2007-2016 . 95
  9. 9. Cymbalta Sales Trend, 2007-2016 99Viagra/Revatio Sales Trend, 2007-2016 . 103Latest Market Research Reports: Global SMT Soldering Equipment Markets Indian Intelligent Building Management Systems Market (2011-2016) Indian Intelligent Building Management Systems Market (2011-2016) Global Solar Inverter Markets Global Home Energy Management Systems Products Market GPCRs in Drug Discovery – Efforts to De-Orphanize Novel GPCR Targets are Increasing Central Nervous System Disorders Therapeutics Market to 2017 – Multiple Sclerosis, Major Depressive Disorder and Schizophrenia Accounted for Half the Market Value in 2010About Us:ReportsnReports is an online library of over 75,000 market research reports and in-depthmarket research studies & analysis of over 5000 micro markets. We provide 24/7 online andoffline support to our customers. Get in touch with us for your needs of market researchreports.Follow us on Twitter: http://twitter.com/marketsreportsOur Facebook Page: http://www.facebook.com/pages/ReportsnReports/191441427571689Contact:Mr. Priyank7557 Rambler road,Suite 727, Dallas, TX 75231Tel: + 1 888 391 5441E-mail: sales@reportsandreports.comhttp://www.reportsnreports.comVisit Our Blog : Market Research Reports

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