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

Top Quote 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. End Quote
  • (1888PressRelease) December 14, 2011 - The 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 only biological class where biosimilars have been launched in the US. However, despite being in the market for a considerable amount of time and priced 30-35% lower than branded HGH products; the market shares of both of these products have so far been dismal. In 2010, the combined sales of the two products represented only 4.5% of the total US HGH market.

    Despite its slow start, a new study from IMARC Group expects that biosimilars in the US will represent a multibillion dollar market in the coming years. The report states that the performance of HGH biosimilars cannot be taken as an analogue to project the uptake of other biosimilar classes as penetration rates of different biosimilars are expected 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 providers

    Findings from the report suggest that the dismal performance of HGH biosimilars was mainly due to the fact that the patient pool for this drug is represented by children where physicians are quite reluctant to switch patients to a drug where very little safety data is available. Moreover, HGH is given for a defined period of time where the benefits or side effects can be lifelong and are not immediately observable. The report expects a much faster uptake of biosimilars in other therapy areas such as ESAs and Insulin which are mainly taken by adults and where the benefits and side effects from the drug would be clearly observable in a short time frame. Similarly, the uptake of Monoclonal Antibody biosimilars are also expected to be faster than HGH biosimilars as the annual cost of therapy for branded versions of these drugs can run into hundreds of thousands of dollars. The savings for payers and providers from the launch of Monoclonal Antibody biosimilars would be much higher than that compared to HGH biosimilars.

    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 been undertaken using desk-based as well as qualitative primary research, provides and draws upon analysis of six aspects of the US biosimilar market.

    Key Aspects Analyzed:

    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 biosimilars

    Evaluating 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 classes

    Evaluating 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 forecasts

    Evaluating the Sales of Biosimilars across Various Indications:
    Indications Covered: Immunology & Inflammation, Diabetes, Oncology, Blood Disorders and Growth Deficiency
    Focus of the Analysis for Each Indication:
    • Historical brand sales
    • Brand and biosimilar sales forecasts
    • Indication wise breakup of molecules

    Evaluating the Biosimilar Competitive Landscape:
    • Identifying branded biological manufacturers that expect the highest amount of erosion from biosimilars
    • Identifying biosimilar manufacturers and their pipelines

    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 Exclusivity
    Statutory provisions for dealing with patent litigations

    To buy the complete report or to get a free sample, please contact:
    IMARC Group Asia
    Email: apac ( @ ) imarcgroup dot com
    Phone: +91-120-425-6531
    IMARC Group North America
    Email: america ( @ ) imarcgroup dot com
    Phone: +1-631-791-1145
    To know more please visit: http://www.imarcgroup.com/

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