Rationale, Opportunities, and Reality of Biosimilar Medications

Biologic therapies for cancer and other disorders contribute to improved outcomes for many patients but also account for a large proportion of health care expenditures. Opportunities for cost containment may emerge as the patents on originator products expire and highly similar agents known as biosimilar medications reach the clinic. Biosimilar formulations of myeloid growth factors that are used to reduce chemotherapy toxicity are already available, and the recent approval of what is likely to be the first wave of biosimilar cancer therapies will provide treatment options that, if accepted by providers and patients, may help constrain health care spending. In this article, we summarize the current status of biosimilar agents in the United States. Although we focus on oncology, the regulatory issues and challenges related to naming, labeling, and postmarketing surveillance, as well as challenges related to implementation in practice (including compliance with guidelines, coverage, and reimbursement), are relevant across all medical disciplines. Considerable professional and patient education will be important, along with rational and sustainable policies, to ensure the appropriate and effective use of biosimilar medications in clinical practice. Copyright © 2018 Massachusetts Medical Society.