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26. Dr. Nikolai Demidov - IMS Health
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“Biosimilars in the world of bio-products: war and peace, missed expectations and future hopes” …

“Biosimilars in the world of bio-products: war and peace, missed expectations and future hopes”

Explores the role and growth of biosimilars worldwide

Published in Health & Medicine , Business
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  • 1. Insert date hereBiosimilars in the world of bio-products: war and peace,missed expectations and future hopesNickolai DemidovConference on bio-products, IMS Health, Moscow, May 16th 2013
  • 2. Biosimilars promised the Moon but did not deliverWere we expecting too much and has anything happened to changeour views?Forecast for2020Historic estimationfor 2011 (in 2007)Today’s actualsales*Source: Suzanne M. Sensabaugh. Biological generics: A business case (2007) Journal of Generic Medicines 4 , 186-199, * MAT 03/2012Биотерапевтические лекарственные препараты - аспекты безопасности и иммуногенности.Москва 15.05.2013-16.05.2013
  • 3. Biosimilars have established a role in many countriesPositive moves are apparent, but still much has to changeUS guidance onbiosimilarsBiosimilarsroadmapLatest EU trendsJapan legislationand launchEastern AsiadynamicsFirst MAbs submittedin EUOngoing BigPharma dealsAusterity measuresdemand biosimilarsPhysicians reactionincreasingly positiveTomorrow’sworldAn opportunity,still to be deliveredTodayPatientsFinancial returnsfor aspiring playersHow have events and key stakeholders been shapingthe biosimilars landscape?AuthorisedbiosimilarsPayer supportUn-affordablemedicinesPotentialbiosimilars pipelineLife-cyclemanagementБиотерапевтические лекарственные препараты - аспекты безопасности и иммуногенности.Москва 15.05.2013-16.05.2013
  • 4. This trend is supported both from demand and supply driversMature economies look at them in the attempt to stem costs;emerging ones to ensure access and sustainable growthBIOSIMILARSTRENDSDemand side Supply side Cost-saving lever formature economiesexperiencing increasingpressure on resources Growth engine foremerging economies whileensuring broader access tomedicines andsustainability Regulatory framework stillfragmented across regions Exposure to biosimilar realworld evidence limited to afew areas (mostly Europe) Increasing inflow of capitaland “branded” capabilitiesthrough BigPharma andmore “unusual” players(Samsung, Fujifilm, GEHealthcare) Increasing specializationalong the value chainunlocking the potential ofsuccessful partnerships Biologics capacityoversupply, pushingmanufacturers to find waysto leverage unexploitedcapacityБиотерапевтические лекарственные препараты - аспекты безопасности и иммуногенности.Москва 15.05.2013-16.05.2013
  • 5. Biologics growth is nearly double that of total pharmaPutting additional financial pressure on healthcare budgetsSource: IMS Health, MIDAS, MAT 09/20120%2%4%6%8%10%12%14%16%0204060801001201401601802006 2007 2008 2009 2010 2011 2012Sales,US$billionsBiologics Sales Biologics GrowthTotal Pharma growth2,6%5,4%21,9%9,2%12,5%48,5%Canada E7 EU5JAPAN Others US4,3%11,6%13,3%9,2%12,2%49,5%Biologics – Share of salesBiologics – Share of growthGlobal market trendsMAT 09/2012, US$Биотерапевтические лекарственные препараты - аспекты безопасности и иммуногенности.Москва 15.05.2013-16.05.2013
  • 6. Three geographical clusters existEmerging economies anticipated to be a potential growth driver due tolocal policies and lower regulatory hurdles7% 10% 10% 14% 14% 14% 23% 11% 27% 19% 59% 45%Biologics,2006-11CAGR731. USPotentialleadingmarket forbiosimilars2. Advanced economiesEstablished framework forbiosimilars, but slowuptake3. Emerging economiesFollow-on biologics* already established(looser regulatory pathway) and fast-growing biologics marketSource: IMS MIDAS, 2006-11Биотерапевтические лекарственные препараты - аспекты безопасности и иммуногенности.Москва 15.05.2013-16.05.2013
  • 7. The global regulatory framework is still quite heterogeneousSome key emerging markets still lag behind in terms of regulatoryguidanceLack of a clearframeworkFully establishedframeworkREGULATORY FRAMEWORKMATURITYEstablishedbiosimilarlegislation andguidancealigned to EMAframework.Fully establishedframework and soliddraft guidance forbiosimilar Mab.Substitution notallowedGuidance published.Global referenceproduct acceptedBehind in terms ofregulation,particularly onclinical requirementsand length ofregulatory processGuidance finalized in2010. Dual pathwaywith abbreviatednon-clinical andclinical dataGuidance recentlyfinalized (Apr 2012),although it does notset clear clinicalcriteria for biosimilarapproval (case-by-case approach)Establishedbiosimilar legislationand guidance(PMDA)Unclear regulatoryframework, limitedclinical requirementsLegal pathwayestablished,FDA guidelinespublished.Pathway nottested yetPatient ethnicity, Opportunity to leverage evidence from other geographies, PK testing,Clinical testing requirements, InterchangeabilityCurrent hurdles to global biosimilar marketБиотерапевтические лекарственные препараты - аспекты безопасности и иммуногенности.Москва 15.05.2013-16.05.2013
  • 8. Three documents to addressthe biosimilar approvalpathway1. Scientific considerations indemonstratingbiosimilarity to a referenceproduct2. Quality considerations indemonstratingbiosimilarity to a referenceproduct3. Biosimilars: Questionsand Answers regardingimplementation ofthe BPCI Act of 2009Will the latest US guidance unlock potential upside scenarios?The totality of evidence principle could favour approval of biosimilarsmarketed in other geographiesUS guidance: the facts OutcomesTotality of evidence principleClear framework to identify criteria todesign clinical studies to provebiosimilarityAllowance of slight differences with RP,especially on delivery technologiesMore interactive process with FDA than thenormal biologics pathwayInterchangeability still a theoreticalconcept for the time beingБиотерапевтические лекарственные препараты - аспекты безопасности и иммуногенности.Москва 15.05.2013-16.05.2013
  • 9. 0%10%20%30%40%50%60%70%80%90%100%Jun-07 Dec-07 Jun-08 Dec-08 Jun-09 Dec-09 Jun-10 Dec-10 Jun-11 Dec-11 Jun-12%Uptake,SUBiosimilar uptake across EuropeMAT 06/2007 – 09/2012 (Volumes, SU)AUSTRIA BELGIUM FRANCE GERMANY GREECEITALY ROMANIA SPAIN SWEDEN UKTotal 10 countries314M €MAT 09/2012Fast uptake at launch, now matureConsistent uptakeSlow uptake, cultural resistanceFast growing due to faster growingmarket trendBiosimilar replacedoriginator supplyIn Europe, biosimilar uptake varies widelyA few countries have reached or approaching maturitySource: IMS MIDAS, MAT 09/2012Биотерапевтические лекарственные препараты - аспекты безопасности и иммуногенности.Москва 15.05.2013-16.05.2013
  • 10. Although the opportunity for volume expansion is therapy area(and geography) dependentHuman GrowthHormone and otherorphan drug biologicsshow typically show highpercentage of availablepatients treatedErythropoetins foroncologyErythropoietin forrenal dialysisOncological biologicsalways have thecompetitive threat ofinnovation to reducevolume for biosimilarsOncological biologics insome European countries(eg UK) show significantlylower levels of use thanelsewhere on costgroundsFilgrastim has alreadyshown price elasticityBiologics forautoimmune showhighly variable levels ofuse across patientpopulations, driven byaccess in Europe (>5% ofpatients to >30% acrossEurope*)• Largest volume expansionpotential undoubtedly inpharmerging, but probablyat a much lower price point• Europe has lower and alsovariable biologic uptakerelative to US• US has highest penetrationof biologics/head – leastvolume expansion potential?• Volume expansion potentialwill also be affected byintroduction of new, betterinnovative therapies (egpertuzumab, Roche)Биотерапевтические лекарственные препараты - аспекты безопасности и иммуногенности.Москва 15.05.2013-16.05.2013
  • 11. Among the new TAs, anti-TNF and MAbs are the key onesAlong with insulins, another key investment area for biosimilar players,they account for more than 40% of the overall biologic marketExistingAnti- TNF; 14,0%Insulins; 13,8%Antineoplastics(Mabs); 11,4%g- CSF; 7,0%Vaccines; 6,2%EPO; 5,3%Interferons; 4,3%Heparins; 4,1%Blood Coagulation;3,5%Immunoglobulins;2,4%OcularAntineovascularisation Products; 2,4%Cytostatic Hormones;2,1%Growth Hormones;2,1% Others; 21,4%Top Biologic Therapy Area, Global Sales(MAT 09/2012)(It includes oldgeneration insulinswhich are unlikely to betargeted by biosimilarplayers)Source: IMS MIDAS, 09/2012Биотерапевтические лекарственные препараты - аспекты безопасности и иммуногенности.Москва 15.05.2013-16.05.2013
  • 12. Twelve compounds represent US$ 67 billion threat fororiginatorsAll these products will lose patent protection by 2020, except Enbrelwhere US patent has been extended until 2028EU expiry date US expiry date2018 20162015 2028 (extended)2014 20182014 20142013 20162019 20172012 Expired2015 20152014 20192017 20152015 20142016 2016Not considered existing biosimilarssuch as Epoetin Alfa expired in EU, butstill patent protected in USSource: IMS MIDAS, 09/2012, IMS Patent focus10504.9Trastuzumab (Herceptin)5.0Interferon Beta-1A (Avonex, Rebif)5.0Bevacizumab (Avastin)5.3Rituximab (Mabthera)5.9Insulin Glargine (Lantus)6.2Infliximab (Remicade)Ranibizumab (Lucentis)4.0Pegfilgrastim (Neulasta)4.3Glatiramer Acetate (Copaxone)4.3Insulin Aspart (Novomix, Novorapid)7.1Etanercept (Enbrel)7.3Adalimumab (Humira)8.1Global Sales (MAT 09/2012), US$ billionTotal~ US$ 67billionБиотерапевтические лекарственные препараты - аспекты безопасности и иммуногенности.Москва 15.05.2013-16.05.2013
  • 13. Monoclonal antibodies dominate the biosimilars pipelineClass Preclinical Phase I Phase II Phase III Prefiling/PendingmAb immunomodulators 55 4 4 2 1Cytotoxic Mabs 28 5 1 3 0Other hormones (excl. insulins) 19 3 1 6 0G-CSF 16 1 3 6 1Insulin 14 4 3 3 1Others (enzymes, BCF) 15 3 2 0 3Interferons 14 3 3 1 1Erythorpoietin 14 1 1 5 0Immunomodulators 8 1 1 2 1Total 183 25 19 28 8Biosimilars pipeline by classSource: FirstWord September 19th 2012Биотерапевтические лекарственные препараты - аспекты безопасности и иммуногенности.Москва 15.05.2013-16.05.2013
  • 14. Biosimilars have been a hot topic in the last 3 yearsThe landscape is becoming over-populated. Is there a market foreverybody?Innovator companies Generics companies Other playersCRAMS* providers / Emerging market domestic players*CRAMS, Contract Research and Manufacturing Services ** Based on press release newsPotentialentrants**(Fujifilm Kyowa Kirin Biologics)Биотерапевтические лекарственные препараты - аспекты безопасности и иммуногенности.Москва 15.05.2013-16.05.2013
  • 15. Original manufacturers will employ a range of defenceapproaches to contain the impact of biosimilarsModerate risk to originalbrandFocus on brand value/patientsegments:Consider splitting businesshigh value brand and a lowprice alternativehighhighHigh risk to original brandFile legal challengesConsider new IP protectedofferingsFight on price, if you areprepared to go to commoditylevelsModerate risk to originalbrandFight on price even wherediscounts are low: ensurethat small price discounts donot let biosimilars gainsignificant tractionLow risk to original brandFocus on building brand valueand patient/prescriber loyaltyMonitor market closely todetect signs of movement toone of the other scenarios• New IP (for exampleRoche’s pertuzumab,Amgen’s Neulasta) isthe most effectivemeasure to protectbrands• HgH has shown thatbrand loyalty canprotect under certaincircumstances – for aperiod of years• Current experience hasnot been ofinterchangeablebiosimilars (USA), orsubstitution (Europe).Either is likely to be agame changerPriceincentives(high/lowdiscount)Willingness to use (physician/patient acceptance)Биотерапевтические лекарственные препараты - аспекты безопасности и иммуногенности.Москва 15.05.2013-16.05.2013
  • 16. New biologics represent a threat for upcoming biosimilarsWhen engaging stakeholders, the biosimilar value proposition shouldinclude both the originator and follow-on biologics in the same TABiosimilarsOriginators New biologics(future generation)adalimumabrituximabtrastuzumabetanerceptinfliximabinterferonbetacetuximabinsulinsbevacizumabSimponiCimziaOther JAK-1inhibitorsNovel OADstofacitinibOmontys(peginesatide)Perjeta(pertuzumab)KadcylaБиотерапевтические лекарственные препараты - аспекты безопасности и иммуногенности.Москва 15.05.2013-16.05.2013
  • 17. How could this market develop?• Commodity biosimilars?• Added value biosimilars?• Authorised biosimilars?• Originator controlled through strategic pricing and life-cyclemanagement?• Biobetters?One thing is certain.The current situation with biologics is unsustainable for payersБиотерапевтические лекарственные препараты - аспекты безопасности и иммуногенности.Москва 15.05.2013-16.05.2013
  • 18. -1002003004005006002005 2006 2007 2008 2009 2010 2011 2012Russianmarketsize,RubBlnBIOLOGIC PRODUCTS OTHERSCAGR2005-2012+17%+15%+27%Russian Biologic market evolutionBiologics significantly outpace total pharma market growthSource: IMS Health. Retail and hospital market – pharmacy purchasing prices; DLO – contract pricesБиотерапевтические лекарственные препараты - аспектыбезопасности и иммуногенности. Москва 15.05.2013-
  • 19. 010203040506070802005 2006 2007 2008 2009 2010 2011 2012Russianbiologicalmarketsize,RubBlnDLO Hospital RetailRussian Biologic market developmentDLO drives biologics market since it was established in 2005Source: IMS Health. Retail and hospital market – pharmacy purchasing prices; DLO – contract pricesБиотерапевтические лекарственные препараты - аспектыбезопасности и иммуногенности. Москва 15.05.2013-
  • 20. 25Rank Corporation MS, %Growth,%1 ROCHE* 19,3% 26%2 SANOFI-AVENTIS 8,8% 6%3 TEVA* 7,6% 38%4 BAXTER INT 5,3% -4%5 MERCK SHARP DOHME* 4,3% 18%6 NOVO NORDISK 4,1% -3%7 MATERIA MEDICA 4,1% 16%8 LABORATORIO TUTEUR 3,7% 97%9 FERON 2,3% 1%10 OCTAPHARMA 2,2% 0%Total Top 10 62% 18%Russian Biologic market structureTop 10 market leaders by sales value in 2012Source: IMS Health. Retail and hospital market – pharmacy purchasing prices; DLO – contract prices, *OOP market is maindistribution channelRank Trade name MS, %Growth,%1 MABTHERA 9,6% 34%2 COPAXONE TEVA 7,0% 37%3 HERCEPTIN 3,5% 25%4 GENFAXON 3,4% 89%5 ANAFERON* 3,0% 5%6 REMICADE 2,9% 24%7 LANTUS SOLOSTAR 2,7% 10%8 CLEXAN 2,4% 24%9 VIFERON* 2,3% 1%10 COAGIL-VII 2,1% 9%Total Top 10 39% 27%Leading corporations Leading productsБиотерапевтические лекарственные препараты - аспектыбезопасности и иммуногенности. Москва 15.05.2013-
  • 21. 267,1 7,59,912,413,314,816,217,619,421,123,526,32007 2008 2009 2010 2014E2013E20122011Total Pharmaceutical market SalesLC$B (ex-mnf), 2006-2017Regionalisation of DLOCrisis2009New pricingsystem 2010CAGR %(2007-17)13.4%10%17%Druginsurance2015ESource: IMS Health market Prognosis, March 2013DriversConstraintsLong term forecastNavigating different alternatives we are still positive aboutattractiveness of the Russian market2016E• Slow economy recovery• EDL pricing/ Restrictionson price registrations• An investigation into stateprocurement and changesto the state procurementrules could result in lowerprices in the DLO andhospital sectors• Price increases forproducts not included inthe EDL will drive pricegrowth in the retail market• Introduction of Druginsurance in a mid/longterm range2017E2006Биотерапевтические лекарственные препараты - аспектыбезопасности и иммуногенности. Москва 15.05.2013-