FDA Seeks Input on Biosimilar Promotion Guidance

Disclaimer: Solli provides this summary as an informational service only. We are not interpreting regulatory intentions nor providing guidance or advice. We encourage our readers to engage directly with the original sources for comprehensive understanding and to form their own interpretations.

The U.S. Food and Drug Administration (FDA) has recently issued a draft guidance for the industry on promotional labeling and advertising practices concerning prescription biological reference products, biosimilar products, and interchangeable biosimilar products. This document is open for public comment and is not final. Industry stakeholders are encouraged to submit their feedback before the deadline.

Key Points of the Guidance

• Promotional Communications: It stresses that promotional materials should be consistent with FDA-approved labeling, clearly identify the specific products (reference or biosimilar), and ensure that any claims made about the products are supported by evidence and comply with FDA regulations.
• Biosimilarity and Interchangeability: The guidance clarifies the definitions and regulatory implications of biosimilarity and interchangeability. It explains that a biosimilar is highly similar to the reference product, notwithstanding minor differences in clinically inactive components, and there should be no clinically meaningful differences in safety, purity, and potency.
• Data Presentation: It discusses how to present data and information about reference products or biosimilar products in promotional materials, ensuring accuracy and compliance with regulatory standards.
• Comparative Claims: The guidance advises caution when making comparative claims about reference products and biosimilar products in promotional materials, emphasizing that such claims should not suggest clinically meaningful differences unless supported by evidence.
• Regulatory Compliance: It provides information on how to handle promotional communications concerning FDA regulations, including the need for promotional materials to be submitted to the FDA at the time of their initial dissemination.

Next Steps for the Industry

Professionals in the pharmaceutical media space are advised to review the draft guidance personally to thoroughly understand the proposed changes and their potential implications. To provide feedback or seek clarifications, stakeholders should submit their comments electronically via the FDA’s regulations portal or send written comments to the address provided in the document. The FDA has set a deadline for receiving comments, which is 60 days from publishing the draft guidance in the Federal Register.

To read the official documents and contribute click here.