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    Biosimilars: A New Look on Process Innovation and the Impact of Competitive Dynamics

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    Genre
    Thesis/Dissertation
    Date
    2018
    Author
    Knighton, John Edward
    Advisor
    Mudambi, Ram, 1954-
    Deeds, David
    Committee member
    Di Benedetto, C. Anthony
    Dhanaraj, Charles
    Department
    Business Administration/Strategic Management
    Subject
    Business Administration
    Health Care Management
    Biosimilars
    Competitive Dynamics
    Market Entry
    Process Innovation
    Permanent link to this record
    http://hdl.handle.net/20.500.12613/3129
    
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    DOI
    http://dx.doi.org/10.34944/dspace/3111
    Abstract
    As healthcare costs are rising globally and biologic treatments are a growing segment of the cost, governments have created biosimilar regulatory pathways in attempt to lower the costs of biologics. Biosimilars may be viewed as a “pure” or distinct type of process innovation completely separate from product innovation due to the Regulatory requirements and this novel phenomenon allows, perhaps for the first time, process innovation to be studied independently from product innovation. This phenomenon is researched using the competitive dynamic Awareness-Motivation-Capability (AMC) model structure. Since biosimilars are still relatively new, the impact of the biosimilars from a practical and academic viewpoint is emerging and in particular within the US market. This research creates a biosimilar model and metrics, filling a current gap in the literature, and quantitatively evaluates the actions that firms face regarding entering into the biosimilars market due to key metrics such as patent / portfolio risk, prior biologics or generic experience, strength of the R&D pipeline, and the firm’s R&D intensity. The biosimilar construct due to the strict regulatory pathway definition provides this unique and novel opportunity to study process innovation and the impact on competitive dynamics without the interference of product innovation. This research is anticipated to contribute to the practical and academic understanding of process innovation via the biosimilar phenomenon and the competitive dynamics of market entry as well as to promote further managerial research into this area of biosimilars.
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