Regulatory NewsBREAK: The FDA Releases Final Guidance on Promotional Labeling and Advertising for Prescription Biologicals, Biosimilars, and Interchangeable Biosimilars

• On December 9, 2025, the Food and Drug Administration (FDA) released final guidance on promotional labeling and advertising for prescription biological reference products, biosimilar products, and interchangeable biosimilar products (Final Guidance). 
• The Final Guidance addresses common industry questions on FDA-regulated promotional communications for prescription reference products or prescription biosimilar products. The Final Guidance includes the following points: 
  • All material facts must be disclosed, and risk information must be presented alongside effectiveness claims. 
  • Promotional materials should be updated quickly if there are changes to FDA-approved labeling, especially regarding risk information. Promotional communications must not imply significant differences in safety, purity, or potency between a biosimilar and its reference product unless supported by evidence.
  • Postmarketing reporting requirements apply: all promotional materials must be submitted to the FDA when first distributed, along with the appropriate forms.
  • No unresolved issues or specific deadlines were noted; more information and training resources can be found on the FDA website and SBIA program. 

More on This Topic:

• Final Guidance   
• Draft Guidance  

For questions, please reach out to Vicky Jucelin.