
FDA Promotes Biosimilars Use
The agency has published educational material for physicians promoting the benefits of biosimilars.
On October 23, 2017, FDA launched an educational campaign and published
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
“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
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.
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