Why Should Healthcare Exhibit and Event Professionals Care About FDA Guidance on Promotional Labeling and Advertising for Biosimilars?

Let's jump right in. First, let’s understand the purpose of the FDA Guidance on Promotional Labeling and Advertising for Biosimilars:

• Ensure promotional communications are accurate, truthful, and non-misleading.
• Provide requirements for the content of promotional communications for biosimilars and reference products.
• Offer recommendations and examples, especially for interchangeable biosimilars.
• Clarify the concepts of biosimilarity and interchangeability.
• Emphasize the importance of data quality and proper disclosures in promotions.
• Advise caution in making comparisons to avoid misleading presentations.
• Help the industry develop FDA-compliant promotional materials and communications.

Revised Guidance document: Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers (fda.gov)

What Does “Promotional” Mean?

• Promotional refers to activities, materials, or communications intended to advertise, market, or promote a product or service.
• In the FDA guidance context, it pertains to advertising and marketing efforts aimed at informing and persuading healthcare providers and consumers about prescription biological reference products and biosimilar drugs.
• These activities aim to increase awareness, encourage use, and highlight the benefits and features of these products.

?Key Points of the Revised Guidance:

• Accuracy and Honesty: Promotional materials must be factually correct, honest, and not deceptive.
• Content Requirements: The guidance outlines what must be included in promotional content to meet regulatory standards.
• Recommendations and Examples: Additional advice and examples are provided, especially for interchangeable biosimilars.
• Biosimilarity: Clarifies that biosimilars are highly similar to their reference products, differing only in inactive ingredients.
• Interchangeability: Requires proof that interchangeable biosimilars produce the same clinical results as the reference product without greater risks.
• Presentation and Disclosure: Stresses the need for clear, high-quality data presentation and full disclosure in promotional materials.
• Caution in Comparisons: Warns against making misleading comparisons between reference products and biosimilars.

Why It Matters to Healthcare Exhibit and Event Professionals:

While creating the actual content for promotional materials is the role of marketing and legal and regulatory departments, exhibit and event professionals that have an understanding the FDA's revised guidance develop a heightened sensitivity and to the challenges our clients face. Whether designing an exhibit booth, creating an event, or developing educational rosters, this heightened awareness of promotional guidelines makes us a more valuable partner. We can add value in unexpected ways by truly understanding our clients' needs and constraints.

By staying informed about these guidelines, we are a true partner contributing to our client's success.

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To learn more about how P&O can help you with your exhibit and event needs, contact a member of the P&O team.