Abstract
This chapter provides an overview of the biosimilar market in the U.S. Biosimilars are defined as highly similar to the originator biologic. Biologics are some of the highest priced drugs that treat some of the most serious diseases. The R&D for biologics can be in the billions of dollars. Recently, patents on various biologics have expired, opening up the market to competition from biosimilars. An abbreviated pathway for biosimilars was created through the 2009 Biologic Price Competition and Innovation Act. Seven biosimilars have been approved with only 3 on the market. Exclusivity and patents and the various legal issues that biosimilars face are examined. We examine the potential gains from biosimilars and the future market structure of the biosimilar market. This analysis will help potential biosimilars producers take a holistic view towards the challenges and prepare for the upcoming competition in making biosimilars a reality.
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Blackstone, E.A., Fuhr, J.P. (2018). Innovation, Patents and Biologics: The Road to Biosimilar Competition: Factors Influencing Investment, Business Decisions and Marketing of Biosimilars. In: Gutka, H., Yang, H., Kakar, S. (eds) Biosimilars. AAPS Advances in the Pharmaceutical Sciences Series, vol 34. Springer, Cham. https://doi.org/10.1007/978-3-319-99680-6_2
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