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  1. From Our Perspective

Education Efforts to Help Increase Biosimilar Understanding and Acceptance

By: Sarah Ikenberry, M.A., Senior Communication Advisor, Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, CDER

Sarah Ikenberry Photograph

A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved biological product (biologic), also known as a reference product. Biosimilars are proven to be a safe and effective alternative to the reference product and may be offered at a lower cost.

FDA approved the first biosimilar in 2015, and there are now 45 FDA-approved biosimilars, including seven interchangeable biosimilars that may be substituted for the reference product without consulting the prescribing health care professional (this practice is called pharmacy-level substitution and depends on state law).

Hesitancy about using biosimilars may, in part, be due to lack of experience with the products, but it may also be due to a general lack of understanding of what they are and how FDA reviews and approves them. In response to this issue, CDER’s Office of Therapeutic Biologics and Biosimilars (OTBB) has created resources to promote understanding of biosimilars, as outlined in the Biosimilars Action Plan (BAP). These programs include a variety of multimedia resources, online outreach, and other educational tools to inform patients and health care providers about the benefits and safety of biosimilars while dispelling misinformation.

Patient Education Outreach

Patients seeking information on biosimilars can access the Biosimilar Basics for Patients page on CDER’s biosimilar information website. Visitors will find easy-to-read summaries about biosimilars with links to find more information. The page also features definitions, frequently-asked-questions, and a link to information about FDA-approved biosimilars. From there, patients can navigate to the Multimedia Education Materials for Patients page to explore fact sheets, infographics, and videos on biosimilars. Multimedia resources are valuable learning tools, as studies have shown them to be more effective than text alone, and they can appeal to a greater number of learners. One example is a three-minute video where we present the definition of biosimilars, an overview of their production, the FDA approval process, and important safety data through illustrations with a voice-over explaining the concepts. The multimedia page also contains materials designed for specific audiences, such as people with diabetes who use insulin, a commonly used biologic. Patients with diabetes can find their own fact sheet with information about the safety, effectiveness, and potential cost advantages of choosing an insulin biosimilar.

In another effort to educate patients, OTBB has added biosimilar education outreach to health care professional waiting rooms. A 30-second public service announcement video explaining biosimilars now plays in more than 700 rheumatology, neurology, and endocrinology specialist offices across the nation. To reach an even wider audience, a Spanish language version of the video was filmed in January 2024 and will be available over digital media in the coming months.

Health Care Professional Resources and Education

Just as patients have a basic biosimilar information page, CDER has created a basic information page for health care professionals. This webpage focuses on more in-depth scientific information to assist health care professionals with making informed decisions for prescribing biosimilars to their patients. There is also a link to multimedia resources created for health care professionals with fact sheets, infographics, videos, and other educational resources to help explain the biosimilar approval process, safety information, availability, and common prescriber concerns. Health care professionals can find links to continuing education materials on Medscape, a site dedicated to providing medical news and expert perspectives. There are also curriculum materials available here for health care degree programs to help incorporate content about biosimilars into the syllabus.

Health care professionals often rely on national medical associations and clinical groups for accurate, up-to-date information to aid in prescribing safe, effective medications, like biosimilars, in their practice. CDER has created articles, blogs, presentations, and other education outreach materials for these organizations to help health care professionals learn more about biosimilars.

Reaching a Wider Audience Through Accessibility

As with any resource, the biosimilars materials are only useful when individuals are able to understand the information. As part of the effort to increase accessibility, OTBB has made the resources available in nine different languages, including French, Korean, and Vietnamese. All FDA biosimilar education webpages and multimedia materials are compliant with section 508 of the Rehabilitation Act, which requires accessibility for digitally published material within government agencies. To support this feature, the fact sheets and infographics use contrasting colors, large text, and plain language writing to make them easy to see, read and understand. The educational videos also include closed captioning for individuals with hearing impairment and an auto-translate feature with more than 100 languages available.

Using Popular Online Communities to Offer Education

Not everyone knows they can go to FDA’s website to learn more about biosimilars. To reach a larger number of individuals, OTBB uses Google and its subsidiaries, such as YouTube, to offer biosimilar education. Using Google Search/Display ads, CDER offers a link to their biosimilar education resources that appears when users search “biosimilars” and related key words. Similarly, the YouTube ads provide information on biosimilars and allow the user to click for more information. As of September 2023, these ads have been displayed more than six million times.

OTBB also uses sponsored articles that display in popular online news outlets to reach large audiences. They appear as a standard news article but contain biosimilar educational information written by FDA staff. These articles have appeared in more than 900 news sites and target those who are interested in or could benefit from biosimilars.

Another large online community available for education purposes is Reddit. In June 2023, OTBB Director Sarah Yim, MD, posted a biosimilars AMA (ask me anything) under the subreddit category r/pharmacy, allowing Reddit users to post questions directly to the AMA session feed or submit them via email. The AMA received more than 41,000 views and the questions covered topics from FDA’s approval process for biosimilars to common barriers to biosimilar acceptance.

Looking to the Future

With the exception of 2020, FDA has approved more biosimilars every year since the first approval in 2015. The number is expected to grow as exclusivity ends for more reference products. Keeping pace with this growth, OTBB has already planned new education materials for 2024, including increased social media outreach about biosimilars and committed to post weekly across various channels (X/Twitter, Facebook, LinkedIn, Instagram).

Biosimilar education is reaching thousands of health care professionals and patients, increasing awareness and understanding throughout the U.S. The CDER biosimilar education program will continue to evolve to ensure the public has unbiased information to use when deciding if a biosimilar is right for them.

 
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