In 2010, the US Food and Drug Administration established an approval pathway for biosimilar agents, biological agents with an active ingredient highly similar to the reference biological agent, to facilitate drug competition and lower costs. It is unclear whether biosimilar drugs could yield large cost savings in the United States given the previously documented market and regulatory barriers.1-3 Moreover, few studies have investigated the real-world safety and effectiveness profile of biosimilar agents compared with that of brand-name (reference) biological agents.
Chen X, Agiro A, Barron J, Debono D, Fisch M. Early Adoption of Biosimilar Growth Factors in Supportive Cancer Care. JAMA Oncol. 2018;4(12):1779–1781. doi:10.1001/jamaoncol.2018.5090
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