PHP38 - Biosimilar Regulatory Policies Issues and Implications: Where are we Headed?

Abstract

Eight biosimilars are currently approved in the United States, accounting for $446 billion alone and is anticipated to grow exponentially by 2020. The goal of this review was to assess the regulatory policy issues and legislative interplay regarding biosimilars in the United States, providing potential insights into possible implications and remedies. A targeted literature review was conducted in PubMed and Google Scholar to identify studies that provided a scientific backbone for the regulatory and legislative issues. An additional targeted search of Westlaw databases was conducted to identify case studies for legislative issues concerning biosimilars. Searches were supplemented with manual citation review of the selected studies and for landmark cases. Regulatory issues impact processes regarding development, approval, manufacturing, and marketing of biosimilars. The regulatory issues identified in this review impact all aspects of the US biosimilar market. Key regulatory policy issues concerning biosimilars included interchangeability with the innovator biologic, extrapolation to another therapeutic area, and reimbursement. We identified 27 cases that directly (16 cases related to biosimilar or pharmaceutical patents) or indirectly (11 cases) affect regulatory process for biosimilars. Biosimilars with structural variability had regulatory and legislative advantages over their innovator biologic, unlike generic drugs. In the patent infringement cases, the court rulings generally upheld the Biologics Price Competition & Innovation Act, favoring biosimilar approval and marketing. Biosimilars hold promise for patients, reducing both patient and national burden of diseases and promoting further research for better healthcare. This review takes a novel approach in the light of the biosimilar patent infringement cases and the corresponding court rulings to better understand the regulatory framework for biosimilar marketing. There is a need for rigorous policy framework from Congress and Food and Drug Administration that promote biosimilar safety, improve patient access, and reduce the cost of biosimilars.