December 06, 2024

The U.S. Food and Drug Administration (FDA) has released updated draft guidance aimed at assisting applicants in developing draft labeling for proposed biosimilar and interchangeable biosimilar products. This guidance is crucial for those submitting applications under section 351(k) of the Public Health Service Act (PHS Act). The recommendations primarily focus on Prescribing Information, with some sections addressing FDA-approved patient labeling.

Key Changes from Previous Guidance

The updated guidance revises and replaces the earlier 2018 document, introducing significant changes in several areas:

  • Labeling for Interchangeable Biosimilar Products: The guidance now includes specific recommendations regarding the labeling of interchangeable biosimilars, which are products that can be substituted for their reference products without the intervention of the prescriber.
  • Product Identification: It addresses scenarios where the reference product’s labeling describes clinical studies conducted with non-U.S.-approved biological products, ensuring clarity in product identification.
  • Pediatric Use Statements: The updated guidance emphasizes the importance of including appropriate pediatric use statements in the labeling.
  • Immunogenicity Data: There is a recommendation to incorporate relevant immunogenicity data and information from reference product labeling into the biosimilar or interchangeable biosimilar product labeling.

The Purpose of Guidance

It is essential to note that FDA guidance documents do not create legally enforceable responsibilities. Instead, they reflect the agency's current thinking on a particular topic and should be viewed as recommendations. The use of "should" in these documents indicates suggestions rather than requirements.

Importance of Accurate Labeling

Accurate labeling is critical in ensuring that healthcare professionals have access to essential scientific information for safe and effective product use. The updated guidance encourages applicants to include a “bio similarity statement” in all labeling for biosimilars, regardless of whether they are approved as interchangeable. This statement clarifies the relationship between the biosimilar and its reference product, enhancing transparency.

Promotional Considerations

In conjunction with labeling guidance, the FDA has also issued revised recommendations regarding promotional labeling and advertising for biosimilars. The emphasis is on ensuring that promotional communications do not mislead healthcare providers or patients regarding the safety and effectiveness of biosimilars compared to their reference products.

  • Avoiding Misleading Comparisons: The FDA advises against promotional materials suggesting that a biosimilar is less safe or effective than its reference product solely based on differences in licensure pathways.
  • Seeking FDA Feedback: Firms are encouraged to voluntarily seek FDA feedback on promotional communications before dissemination, promoting honest and truthful advertising.

Conclusion

The FDA's updated draft guidance on biosimilar labeling ensures transparency and accuracy in product labeling and promotion. At Maven, we provide expert services to help biosimilar manufacturers develop compliant labeling, incorporate immunogenicity data, and meet regulatory requirements. Our support ensures your biosimilars align with FDA guidelines, promoting safe and effective use in the healthcare sector.