FDA Promotes Biosimilars Use

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The agency has published educational material for physicians promoting the benefits of biosimilars.

On October 23, 2017, FDA launched an educational campaign and published educational materials to help physicians understand the benefits of biosimilars. FDA hopes that with better understanding of these treatment options, doctors will be more likely to prescribe the lower-cost option to their patients.

The educational materials provide definitions of biosimilar-related terms, descriptions of the standards biosimilars must meet to be approved by FDA, and information about FDA-reviewed data. The website also includes information on prescribing these therapies and online presentations. The agency plans on continuing to do research on how best to inform healthcare providers about biosimilars.

“An increase in market competition, offered by a growing complement of biosimilars, may lead to meaningfully reduced costs for both patients and our healthcare system. As with the significant savings that we’ve seen through the introduction of generic drugs in the United States, biosimilars could also lead to substantial savings, thereby potentially improving access and promoting better public health outcomes. Understanding the rigorous process FDA uses to evaluate biosimilars can help prescribers and patients maximize the benefits from these products,” said Leah Christl, PhD, associate director for Therapeutic Biologics in the Office of New Drugs, at FDA’s Center for Drug Evaluation and Research, and FDA Commissioner Scott Gottlieb, in a FDA Voice blog post.


An FDA-approved biosimilar product is highly similar to an already FDA-approved biologic. They have the same safety, purity, and effectiveness of their reference product, according to the agency.

Source: FDA