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

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.

Grantor dc:publisher

Temple University. Libraries

Year dc:date.issued

2018

Author dc:creator

• Knighton, John Edward

Advisors dc:contributor.advisor

• Mudambi, Ram, 1954-
• Deeds, David

Committee members dc:contributor.committeemember

• Di Benedetto, C. Anthony
• Dhanaraj, Charles

• Business administration
• Health care management
• Biosimilars
• Competitive dynamics
• Market entry
• Process innovation

Statement dc:rights

• IN COPYRIGHT- This Rights Statement can be used for an Item that is in copyright. Using this statement implies that the organization making this Item available has determined that the Item is in copyright and either is the rights-holder, has obtained permission from the rights-holder(s) to make their Work(s) available, or makes the Item available under an exception or limitation to copyright (including Fair Use) that entitles it to make the Item available.

Licence dc:rights.uri

• http://rightsstatements.org/vocab/InC/1.0/

Language dc:language.iso

eng

Handle dc:identifier.uri

http://hdl.handle.net/20.500.12613/3129

OAI identifier oai:identifier

oai:scholarshare.temple.edu:20.500.12613/3129