Biosimilars in the USA: Will New Efforts to Spur Approvals and Access Spur Uptake and Cost Savings?


Unlike in Europe, US healthcare systems and payers are still awaiting significant savings related to biosimilar utilization. Costs related to biologic use continue to rise at double-digit rates, and biosimilars are seen as a major tool to control costs and increase access to biologic drugs. However, one 2018 report indicated that US$3.2 billion (only 3%) of biologic spending is subject to competition from biosimilar products. Although the European Medicines Agency did a great deal of pioneering work in biosimilar regulation, the US Food and Drug Administration is moving at approximately the same pace as the European Medicines Agency, based on the number of approvals at the same time after implementation of its regulatory pathway. Several unique factors in the USA have conspired to limit biosimilar access (e.g. delayed regulatory policies, extended patent litigation activities, federal reimbursement policies, the widespread use of rebate contracting, and limited competition). The US Federal Government is taking the initiative in an attempt to address these factors, and speed both biosimilar development and patient access. To date, the most significant cost savings in the US system associated with the introduction of biosimilars may be their ability to halt price increases of the reference product. The complexity of the healthcare delivery system, and how it is financed, will remain challenging to payers, manufacturers, health providers and patients as they seek ways to manage health expenditure growth.

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Source: Brook 2018 [37]


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SRM and RAB were both involved in the conception and joint outline of this paper. SRM wrote the initial draft, RAB revised it critically for intellectual content, accuracy, and additional emphasis. Both authors were responsible for the final approval of the published version, and they both agree to be accountable for all aspects of the work.

Corresponding author

Correspondence to Richard A. Brook.

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This paper was not funded by any third party.

Conflict of interest

Mr. Mehr disclosed that he has consulted for Boehringer Ingelheim and Sandoz, and he owns stock in Coherus Biosciences. Mr. Brook disclosed that he has no relevant business to disclose.

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Mehr, S.R., Brook, R.A. Biosimilars in the USA: Will New Efforts to Spur Approvals and Access Spur Uptake and Cost Savings?. Pharm Med 33, 1–8 (2019).

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