Many first-generation biologics will lose their patent protection by 2020. The biosimilars market is not only attractive but also competitive and tough. The United States (US) is the world's largest pharmaceutical market and is critical to the success of most drugs. However, unclear regulatory requirements and confusing patent resolution procedures create hurdles to market entry of biosimilars. Trade secret exposure and scant exclusivity and adoption also limit the market access of biosimilars. Both biologics and biosimilar developers should closely follow the regulatory and litigation landscape to successfully navigate through the challenges. Focusing on the US landscape, this article provides a brief review of the regulatory framework for biosimilar products, market exclusivities, and patent issues under the Biologics Price Control and Innovation Act (BPCIA), analyzes emerging issues in the biosimilar litigation landscape, and provides recommendations for companies entering the biosimilars market.
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