Despite its Slow Start, Prospects for Follow-on Biologics Appear Bright in the US


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The performance of HGH biosimilars cannot be taken as an analogue to project the uptake of other biosimilar classes as penetration rates of biosimilars in different biological classes are expected to be different from one another

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Despite its Slow Start, Prospects for Follow-on Biologics Appear Bright in the US

  1. 1. Despite its Slow Start, Prospects for Follow-on Biologics Appear Bright in the USThe performance of HGH biosimilars cannot be taken as an analogue to project the uptake of other biosimilarclasses as penetration rates of biosimilars in different biological classes are expected to be different from oneanotherThe market for biosimilars in the US is currently at its infancy with its total sales reaching US$ 57 Million in 2010.With Teva’s Tev-tropin and Novartis’s Omnitrope, Human Growth Hormones (HGH) currently represents the onlybiological class where biosimilars have been launched in the US. However, despite being in the market for aconsiderable amount of time and priced 30-35% lower than branded HGH products; the market shares of both ofthese products have so far been dismal. In 2010, the combined sales of the two products represented only 4.5% ofthe total US HGH market.Despite its slow start, a new study from IMARC Group expects that biosimilars in the US will represent amultibillion dollar market in the coming years. The report states that the performance of HGH biosimilars cannot betaken as an analogue to project the uptake of other biosimilar classes as penetration rates of different biosimilars areexpected to be different from one another and will depend upon three key factors:•The complexity of the molecule•The patient pool that it caters to•The extent of savings it brings to payers and providersFindings from the report suggest that the dismal performance of HGH biosimilars was mainly due to the fact that thepatient pool for this drug is represented by children where physicians are quite reluctant to switch patients to a drugwhere very little safety data is available. Moreover, HGH is given for a defined period of time where the benefits orside effects can be lifelong and are not immediately observable. The report expects a much faster uptake ofbiosimilars in other therapy areas such as ESAs and Insulin which are mainly taken by adults and where the benefitsand side effects from the drug would be clearly observable in a short time frame. Similarly, the uptake ofMonoclonal Antibody biosimilars are also expected to be faster than HGH biosimilars as the annual cost of therapyfor branded versions of these drugs can run into hundreds of thousands of dollars. The savings for payers andproviders from the launch of Monoclonal Antibody biosimilars would be much higher than that compared to HGHbiosimilars.IMARC’s new report entitled “Biosimilar/Follow-on Biologics Market Report & Forecast: A Focus on the US(2011-2020)” provides an analytical and statistical insight into the US biosimilar market. The study, that has beenundertaken using desk-based as well as qualitative primary research, provides and draws upon analysis of six aspectsof the US biosimilar market.Key Aspects Analyzed:imarc© 1
  2. 2. Evaluating the Current Market Landscape of Biosimilars: Identification of currently marketed biosimilars and their historical performance Identifying the reasons for the slow uptake of currently marketed biosimilars Analyzing historical data to formulate conclusions on the future growth and market trends of biosimilarsEvaluating the Extent of Price, Sales and Volume Erosions Caused by Biosimilars: Analyzing historical time series data on price, volume and sales erosion in the US & Europe Analyzing previous models and assumptions on price and volume erosion caused by biosimilars Evaluating and comparing price and volume erosion created by biosimilars vis-a-vis by small molecule generics Evaluating and comparing price, volume and sales erosion by biosimilars across various biological classesEvaluating the Market Potential of Biosimilars Across Various Molecules:Molecules Covered: Somatropin (Genotropin/Humatrope/Other HGH), Epoetin Alfa (Epogen/Eprex), Filgrastim(Neupogen), Pegfilgrastim (Neulasta), Insulin Lispro (Humalog), Insulin Glargine (Lantus), Insulin Detemir(Levemir), Interferon Beta-1A (Avonex), Interferon Beta-1A (Rebif), Interferon Beta-1B (Betaferon), Bevacizumab(Avastin), Trastuzumab (Herceptin), Rituximab (Mabthera/Rituxan), Cetuximab (Erbitux), Etanercept (Enbrel),Infliximab (Remicade), Adalimumab (Humira), Ranibizumab (Lucentis), Omalizumab (Xolair) and Natalizumab(Tysabri).Focus of the Analysis for Each Molecule: Historical background and overview Historical brand sales Patent position Competing products Biosimilars in pipeline Brand and biosimilar sales forecastsEvaluating the Sales of Biosimilars across Various Indications:Indications Covered: Immunology & Inflammation, Diabetes, Oncology, Blood Disorders and Growth DeficiencyFocus of the Analysis for Each Indication: Historical brand sales Brand and biosimilar sales forecasts Indication wise breakup of moleculesEvaluating the Biosimilar Competitive Landscape: Identifying branded biological manufacturers that expect the highest amount of erosion from biosimilars Identifying biosimilar manufacturers and their pipelinesimarc© 2
  3. 3. imarc© 3
  4. 4. Understanding the Current Legislation on Biosimilars: An insight into the Biologics Price Competition and Innovation Act An insight into the key biosimilar issues that still remain unaddressed Interchangeability and Substitutability Data ExclusivityStatutory provisions for dealing with patent litigationsTable of Contents1 Market Definitions & Research Methodology2 Executive Summary3 The US Biosimilar Market Landscape4 US Biosimilar Market: Current Experience4.1 The Performance of Growth Hormone Biosimilars Has Been Dismal So Far4.2 Pediatrics Represent the Prime Customer Base for Growth Hormones4.3 Omnitrope Was Launched with an Inconvenient Delivery Device4.4 Prescribing Patterns for Omnitrope4.5 Uptake is Likely to Increase with the Accumulation of Post-Market Safety Data5 US Biosimlar Market: How Much Price, Volume & Sales Erosion will Result5.1 Omnitrope Cannot be Taken as a Benchmark to Gauge the Performance of Other Biosimilars5.2 The European Uptake of ESA & GCSF Biosimilars Give Us a Very Positive Outlook for the US5.3 Models for Biosimilar Volume Erosion Across Various Biological Classes5.4 Models for Biosimilar Price Erosion Across Various Biological Classes5.5 Models for Biosimilar Sales Erosion Across Various Biological Classes6 US Biosimilar Market: Current Trends & Forecast by Drug6.1 Growth Hormones6.1.1 Somatropin (Genotropin/Humatrope/Other HGH)imarc© 4
  5. 5. 6.2 Erythropoiesis Stimulating Agents6.2.1 Epoetin Alfa (Epogen/Eprex)6.3 Granulocyte Colony Stimulating Factor6.3.1 Filgrastim (Neupogen)6.3.2 Pegfilgrastim (Neulasta)6.4 Insulin6.41. Insulin Lispro (Humalog)6.4.2 Insulin Glargine (Lantus)6.4.3 Insulin Detemir (Levemir)6.5 Interferons6.5.1 Interferon Beta-1A (Avonex)6.5.2 Interferon Beta-1A (Rebif)6.5.3 Interferon Beta-1B (Betaferon/Betaseron)6.6T NF Alpha & Monoclonal Antibodies (Immunology & Inflammation)6.6.1 Etanercept (Enbrel)6.6.2 Infliximab (Remicade)6.6.3 Adalimumab (Humira)6.6. Ranibizumab (Lucentis)6.6. Omalizumab (Xolair)6.6.6 Natalizumab (Tysabri)6.7 Monoclonal Antibodies (Oncology)6.7.1 Bevacizumab (Avastin)6.7.2 Trastuzumab (Herceptin)6.7.3 Rituximab (Mabthera)6.7.4 Cetuximab (Erbitux)7 US Biosimilar Market: Current Trends & Forecast by Indicationimarc© 5
  6. 6. 7.1 Immunology & Inflammation7.1.1 Current Trends & Forecast7.1.2 Biosimilar Sales Breakup by Molecule7.2 Diabetes7.2.1 Current Trends & Forecast7.2.2 Biosimilar Sales Breakup by Molecule7.3 Oncology7.3.1 Current Trends & Forecast7.3.2 Biosimilar Sales Breakup by Molecule7.4 Blood Disorders7.4.1 Current Trends & Forecast7.4.2 Biosimilar Sales Breakup by Molecule7.5 Growth Deficiency7.5.1 Current Trends & Forecast7.5.2 Biosimilar Sales Breakup by Molecule8 Competitive Landscape8.1 Branded Manufacturers: Companies Facing the Highest Amount of Biosimilar Erosion8.2 Biosimilar Manufacturers: Companies Gaining the Most From Biosimilar Launches9 Biosimilar Legislation in the US9.1 The Biologics Price Competition and Innovation Act: An Insight9.2 Biosimilar Issues that Still Remain Unaddressed9.3 Major Issues Impacting the Business Strategies of Biological Companies9.3.1 Interchangeability & Substitutability9.3.2 Data Exclusivity9.3.3 Patent Litigationimarc© 6
  7. 7. 10 Key Company Profiles10.1 Teva Pharmaceutical Industries Ltd.10.2 Sandoz, Inc.10.3 Hospira, Inc.10.4 STADA Arzneimittel AG10.5 Dr. Reddys Laboratories Ltd.10.6 Celltrion, Inc.10.7 Bioexpress Therapeutics SATo buy the complete report or to get a free sample:Call: +91-120-425-6531 (Asia),Email: sales@imarcgroup.comTo know more please visit: wordsBiosimilar market, biosimilar industry, follow-on biologics market, biogenerics market, us biosimilar market,biosimilar monoclonal antibodiesimarc© 7