As the cost of healthcare continues to rise and patents on biologics near expiration, biosimilars are gaining visibility as a mechanism for cost reduction. Yet, the introduction of biosimilars into the U.S. market will be complex, due to the related complexity of production, research requirements, and regulatory uncertainty. The purpose of this paper is to frame the relevant issues in order to provide context for stakeholders. It is particularly crucial that clinicians understand the scientific, regulatory, legislative and economic considerations involved in order to ensure that the path to approval is consistent with their needs and that appropriate utilization occurs, once approved.
Keywords: Biosimilar; Follow-on biologic; Health care cost; Specialty pharmaceuticals.
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