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- Presentation
FDA Biosimilars Research Findings and Educational Resources Overview
Description
The speaker described FDA research on biosimilars based on in-depth interviews with patients prescribed biologics and with healthcare providers, including dermatologists, to understand experiences, barriers, information needs, and adoption trends. The findings suggest that biosimilar use is increasing, but decisions are often driven more by insurance coverage than by patients or clinicians. Both patients and providers frequently compare biologics and biosimilars to the brand/generic model, and while FDA is seen as trustworthy, patients do not usually think of FDA as a primary source of information. Because people want very different levels of detail, FDA creates layered materials and is recommending more targeted resources for providers and patients, better use of existing information channels, stronger visibility of FDA resources, and clearer messaging about the value of biosimilars. The speaker also reviewed FDA educational offerings, including website materials for patients and providers, multilingual multimedia resources, Medscape continuing-education courses, a modular curriculum toolkit, the Purple Book database of licensed biological products, and upcoming communications toolkits with disease-specific outreach, PSAs, reference guides, and provider Q&As.
View moreConclusions
- Insurance coverage, more than patient or clinician preference, is the main driver of switching from reference biologics to biosimilars.
- Providers and patients often understand biosimilars most easily when they are explained using the familiar brand-name versus generic-drug analogy.
- Both groups still need clearer, more practical information about biosimilars, including which biologic options are available and how decisions are made.
- FDA is viewed as a trustworthy source, but patients do not naturally turn to FDA for biosimilar information, so visibility and outreach need to improve.
- Because information needs vary from brief summaries to detailed explanations, effective education must offer layered materials for different audiences.
- Targeted resources are needed to help health care providers navigate biosimilar switches, substitutions, and related clinical information.
- The most effective educational strategy is to distribute information through the channels where patients and providers already look for it.
- FDA should emphasize the safety, efficacy, and expanded treatment options of biosimilars to make their value proposition clearer.
- A broad set of FDA biosimilar resources already exists, including patient materials, provider materials, translated content, CE courses, curriculum toolkits, and the Purple Book database.
- Future communication efforts should focus on audience-specific toolkits and disease-specific outreach to further increase biosimilar awareness and use.