FDA Launches New Educational Materials on Biosimilar Therapies


The FDA has released a new set of educational materials concerning the nature and the prescribing of biosimilar therapies.

The FDA has released a new set of educational materials concerning the nature and the prescribing of biosimilar therapies.

The resources are intended to help educate healthcare providers about biosimilars, and include fact sheets and graphics for clinicians as well as materials that organizations can use as they disseminate information about biosimilars to their stakeholders. The resources provide definitions of key biosimilars terms, describe the standards that a biosimilar therapy must meet before it is granted FDA approval, explains the approval pathway for biosimilar products, explains the FDA’s Purple Book (which lists licensed biologics that have reference product exclusivity as well as those that have biosimilarity or interchangeability evaluations), provides accessible information about the data that the FDA reviews when it determines biosimilarity, and gives additional resources for further reading.

Among the features of the new biosimilars educational site are FDA-sponsored webinars and staff presentations, animated GIFs and other sharable social-media assets, and an up-to-date list of the 7 currently approved biosimilar products.

In a blog post announcing the release of these new materials, FDA Commissioner Scott Gottlieb, MD, and Leah Christl, PhD, associate director for therapeutic biologics in the office of new drugs, a part of the FDA’s Center for Drug Evaluation and Research, said that “Biosimilars can potentially reduce costs for consumers by creating price competition for products that previously faced few market competitors. FDA wants to ensure that health care providers have the information they need when considering prescribing biosimilars when these products are available.”

Gottlieb and Christl also said that the agency plans to continue to engage with healthcare professionals in order to gain feedback on the types of education that they require in order to properly communicate with their patients about biosimilars. These efforts will, the agency hopes, increase the uptake of biosimilar medications, drive down the cost of therapy, and improve access to care.

Recent research has highlighted the need to educate providers about the use of biosimilars; a recent study from Cardinal Health Solutions found that, in a survey of oncologists from practices across the United States, 25% of respondents said that they lacked familiarity with biosimilars, 45% said that their practice partners lacked familiarity, and 46% said that they would require additional evidence concerning biosimilars before they felt comfortable with prescribing a biosimilar therapy for a patient.

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