2023-2027美国生物仿制药.pdf

Biosimilars in the United States 20232027 COMPETITION,SAVINGS,AND SUSTAINABILITYJANUARY202 3The first biosimilar approved under the abbreviated pathway established by the Biologics Price Competition and Innovation Act launched in the U.S.in 2015,while some non-original biologics have been approved through other pathways both before and since.Despite slower initial uptake,biosimilar launches in the last three years have generally been more successful than earlier,raising important questions for upcoming biosimilars,where savings and patient access could increase substantially.In this report,the current state of the biologics market in the United States and share of the market facing biosimilar competition are assessed.Factors impacting biosimilar uptake,including reimbursement and provider type,and the impact of biosimilars on molecule volume and price are evaluated.Historic biosimilar trends are utilized to provide potential future biosimilar spending and savings scenarios.We intend for this report to provide a foundation for meaningful discussion about the value and role of biosimilars over the next five years and the key implications stakeholders should consider as budget pressures continue to drive healthcare decision-making in the U.S.This study was produced independently by the IQVIA Institute for Human Data Science,drawing on IQVIA proprietary data.Funding for this research and report has been provided by the Biosimilars Council,a division of the Association for Accessible Medicines.The contributions to this report of Allen Campbell,Sarah Markiewicz,Urvashi Porwal,Vibhu Tewary,Tanushree Thakur,Marcella Vokey,and others at IQVIA are gratefully acknowledged.Find Out MoreIf you wish to receive future reports from the IQVIA Institute for Human Data Science or join our mailing list,visit iqviainstitute.org.MURRAY AITKENExecutive Director IQVIA Institute for Human Data Science2023 IQVIA and its affiliates.All reproduction rights,quotations,broadcasting,publications reserved.No part of this publication may be reproduced or transmitted in any form or by any means,electronic or mechanical,including photocopy,recording,or any information storage and retrieval system,without express written consent of IQVIA and the IQVIA Institute.IntroductionBiosimilars in the United States 20232027:Competition,Savings,and SustainabilityTable of ContentsOverview 2Market dynamics and biosimilar development 4Factors influencing biosimilar uptake 13Biosimilar impacts on molecule volume and price 20Future impacts of biosimilars 26Notes on sources 33Definitions and methodology 34References 35About the authors 36About the Institute 38BIOSIMILAR IMPACTS ON MOLECULE VOLUME AND PRICEThe introduction of biosimilars frequently leads to higher utilization of the molecule as lower costs offer increased access to patients.Over time,the utilization of older treatments subject to biosimilar competition can decrease as more innovative alternative treatments become available.Patient access to successive generations of originator products has narrowed the market ultimately accessible to biosimilars,impacting the potential financial returns for biosimilar developers.Introduction of lower cost biosimilars leads to declines in overall molecule costs per unit(i.e.,includes originator and biosimilars)at invoice prices over time,typically driving down costs for originators as well.Absolute savings from biosimilars vary,with larger savings where originators were more costly including the 2019 biosimilar launches,which have seen ASP reductions of$2,526$4,913,potentially a factor in their high uptake.Off-invoice discounts and rebates likely vary by originator and biosimilar products,reducing the prices experienced by payers,patients,and other healthcare system participants.Price reductions and savings may differ when looking at net prices,including discounts and rebates.The market share maintained by originators after facing biosimilar competition is correlated with the relative price reduction in the originator product compared to the biosimilar.Generally,originators which have reduced prices to similar levels as biosimilar competitors have lost less volume following biosimilar entry,while originators maintaining higher prices see significant volume loss.As a result,the healthcare system tends to see savings through uptake of lower cost biosimilars and/or price reductions for the reference product.FUTURE IMPACTS OF BIOSIMILARSFuture biosimilar sales and savings will depend on a variety of market dynamics.To model this,volume uptake scenarios have been developed including high,medium,and low,tied to both originator competition and price reductions ranging from 1545%.Expected launches and uptake are likely to increase overall spending on biosimilars significantly to$20$49Bn in 2027 and cumulative sales of$129Bn over the next five years,with at least 10 molecules facing biosimilar competition over the period.Savings over the next five years as a result of biosimilars are projected to exceed$180Bn,though uncertainties remain as market events to date suggest a wide range of market outcomes are still possible.The immunology market has seen significant growth in both spending and volume in the last five years,and the entry of new immunology biosimilars in 2023 will increase competition in this rapidly growing market.The best-selling biopharmaceutical in the U.S.,adalimumab(Humira),will face biosimilar competition beginning in 2023,and product characteristics and reimbursement decisions are likely to impact biosimilar uptake.With biosimilars seeing increasing acceptance in the U.S.and the scale of spending on medicines facing upcoming biosimilar competition growing,the impact on all stakeholders will be significant.Savings as a result of biosimilars are projected to exceed$180Bn over the next five years.iqviainstitute.org|34|Biosimilars in the United States 20232027:Competition,Savings,and Sustainability The U.S.biologics market has grown 12.5%annually on average over the last five years on an invoice-price basis,faster than non-biologics,and now comprising 46%of spending.Molecules currently facing biosimilar competition total$38Bn of invoice spending,while a further$96Bn is the target of biosimilars in development or approved but not yet launched.Biosimilars launched to date account for 24%of competitive molecule volume,and 11%of total biologic spending at invoice levels is facing biosimilar competition.Since 2007,30 biosimilars have launched across 12 molecules in the U.S.,with 10 more biosimilars approved and set to launch by the end of 2023.There are biosimilars approved or in clinical development in the U.S.for 20 molecules in addition to the 12 with biosimilars already launched,with biosimilars set to launch for the best-selling biologic molecule,adalimumab,in 2023.In those markets with biosimilars,competitiveness is highly varied but being first to launch is generally a significant advantage.Development of biosimilars is being driven by smaller companies,while marketing is done mostly by large companies.In recent years,smaller companies have begun marketing more biosimilars,a trend that is expected to continue with upcoming biosimilar launches.Market dynamics and biosimilar developmentThe biologics market continues to grow,with 14%of the market facing biosimilar competition,a number likely to grow by 15%in 2023 as biosimilars are expected to launch for molecules with high spending.iqviainstitute.org|5 In 2021,the United States spent$568Bn on medicines at ex-manufacturer invoice prices,including$260Bn on biologics,which now comprise 46%of total medicine spending.Even including the effect of biosimilar competition over the past decade,biologics spending has increased significantly since 2017,at a compound annual growth rate(CAGR)of 12.5%,outpacing the 1.3%CAGR for small molecules and raising the total market CAGR to 5.6%.The three classes with the highest spending immunology,antidiabetics,and oncology account for 70%of biologics spending,and their biologics growth is at 18.4%,12.3%,and 14.8%CAGRs,respectively,in the past five years.Respiratory agents have seen substantial growth in biologics,with 19.7%CAGR since 2017 due to advances in severe asthma treatments.Several biosimilar launches occurred in the top three spending areas in recent years,including biosimilar cancer treatments,insulins,and immunology agents.Additional biosimilars are in development in these classes,as well as in respiratory agents,antithrombotics,and multiple sclerosis products.Smaller classes of medicines,such as growth hormones,osteoporosis treatments,and ocular anti-neovascularization products have biosimilars available,with additional biosimilars in development.Exhibit 1:Total U.S.invoice spending growth by type and leading therapy areas by 2021 spending,US$BnNotes:Oncology includes therapeutic agents as well as supportive care.Invoice prices in this report are ex-manufacturer level,reflecting the prices between manufacturers and their customers(wholesalers or direct purchasers),not including off-invoice discounts and rebates.MARKET DYNAMICS AND BIOSIMILAR DEVELOPMENTThe U.S.biologics market continues to grow faster than non-biologics on an invoice-basis,and now comprises 46%of spendingSource:IQVIA MIDAS,Dec 2021;IQVIA Institute,Nov 2022.12131718262731788490PainVaccinesMultiple sclerosisMental healthHIV antiviralsAntithromboticsRespiratory agentsOncologyAntidiabeticsImmunologyBiosimilars available as well as in developmentLeading drug classes-4%-2%0%2%4%6%8%10%12%14%16%BiologicsSmall moleculeTotal US medicinesBiologicsCAGR 2017-2021:12.5%Total US medicinesCAGR 2017-2021:5.6%Small moleculeCAGR 2017-2021:1.3%Total 2021 US medicinespending$568Bn Biologic46%SmallMolecule54%Year-over-year spending growth20172018201920202021Biosimilars in development6|Biosimilars in the United States 20232027:Competition,Savings,and Sustainability The current$260Bn biologics market is already facing biosimilar competition,with biosimilars launched for 12 molecules representing 14%($38Bn)of biologic spending(i.e.,exposed originators and their biosimilar competitors).An additional 16%of the market,or$41Bn,are biologics produced without recombinant technologies,such as purified or gathered biologics,thereby making it impossible to produce a biosimilar,though in some cases non-recombinant biologics are already facing generic competition as they are naturally occurring substances or vaccines without patent protection.The remaining 70%or$181Bn could face biosimilar competition in the future.Just more than half(53%or$96Bn)of this market currently has biosimilars in development,and the remaining 47%(or$86Bn)has no biosimilars currently in development,with these molecules varying in protection status(see Exhibit 3).Exhibit 2:2021 biologics market segmented by status of biosimilar competition and biosimilar developmentNotes:Generics for non-recombinant biologics include glatiramer acetate,enoxaparin sodium,and a range of vaccines and blood plasma products.Numbers may not sum due to rounding.MARKET DYNAMICS AND BIOSIMILAR DEVELOPMENTMolecules with biosimilars total$38Bn of invoice spending,while biosimilar development is targeting a further$96BnSource:IQVIA MIDAS,Dec 2021;IQVIA Pipeline Intelligence,IQVIA Institute,Nov 2022.Biologics market$260BnMolecules facingbiosimilar competition$38Bn Non-recombinant/vaccines$41Bn70%16%14%47%Molecules with biosimilarsin development$96Bn Molecules without biosimilarsin development$86Bn Molecules with potential future biosimilars$181Bn 53%iqviainstitute.org|7 There are 27 molecules with biosimilars approved or in any stage of development:21 where the originator remains protected by exclusivity and 6 that are unprotected.The 21 molecules with biosimilars in development that are still protected generated$89Bn in sales in 2021 and averaged$4.2Bn.This includes the immunology blockbusters adalimumab(Humira)and ustekinumab(Stelara),which accounted for 40%of this spending and will lose exclusivity in 2023.The six unprotected molecules with biosimilars in development generated$7Bn in sales in 2021 and an average of$1.2Bn.Insulin aspart,which lost patent protection in 2014,accounts for$6Bn of this spending,and a biosimilar has completed Phase III in the U.S.The remaining five molecules averaged$216Mn in sales,with one biosimilar in development each.There are 178 molecules without biosimilar development,comprising the remaining$86Bn.The 145 molecules currently protected generated$77Bn in spending or$532Mn on average.Many of these are recently launched and have not yet generated biosimilar development activity but may in the future.The remaining 33 without biosimilar development are off-patent and generated$9Bn,or an average of$260Mn,and are not likely to see biosimilar development activity due to lower market potential for biosimilar companies.Exhibit 3:2021 biologics market segmented by status of biosimilar development and market exclusivityNotes:Protected is defined as having an expiry date in the future,while unprotected is defined as having an expiry date in the past.Numbers may not sum due to rounding.MARKET DYNAMICS AND BIOSIMILAR DEVELOPMENTMost of the molecules with biosimilars in development continue to be protected,with only 7%unprotectedSource:IQVIA MIDAS,Dec 2021;IQVIA Pipeline Intelligence,IQVIA Institute,Nov 2022.Molecules with biosimilarsin development$96BOriginator protected$89BnOriginator unprotected$7BnOriginator unprotected$9BnOriginator protected$77Bn21 moleculesAvg sales=$4.2Bn6 moleculesAvg sales=$1.2Bn33 moleculesAvg sales=$260Mn145 moleculesAvg sales=$532Mn93%90%10%7%Molecules without biosimilarsin development$86B8|Biosimilars in the United States 20232027:Competition,Savings,and Sustainability Biologic sales currently accessible to and facing biosimilar competition account for 11%of total biologic sales,and biosimilar efficiency meaning the percentage that biosimilars comprise of accessible molecule volume has reached 24%.The potential savings that biosimilars may bring to healthcare stakeholders is often delayed,as is competition,since the approval of biosimilars does not result in their immediate launch.Delays in availability are often due to patent litigation and other logistical issues.Biosimilars that are approved but not yet launched represent an additional 13%of total biologic sales,with 10%from adalimumab,which has biosimilars launching this year,and 3%from etanercept,which is not expected to face biosimilar competition until 2029.The launch of insulin glargine and infliximab biosimilars in 2016 resulted in a significant rise in the accessible market from 2%to 12%within the first quarter and reduction in biosimilar efficiency from 19%to 1%until uptake of biosimilars increased.Exhibit 4:Percentage of biologics sales accessible to approved and launched biosimilars and biosimilar efficiency,Q1 2015Q3 2022Notes:Biosimilar efficiency measures biosimilar share of mar