The US Food and Drug Administration (FDA) announced on 24 April 2024, the availability of a revised draft guidance for industry entitled ‘Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products Questions and Answers Guidance for Industry’.
The revised draft guidance is intended to facilitate applicants in ‘developing FDA-regulated promotional labeling and advertisements (promotional communications) for prescription reference products licensed under section 351(a) of the Public Health Service Act 22 (PHS Act) (42 U.S.C. 262(a)) and prescription biosimilar products, including interchangeable biosimilar products, licensed under section 351(k) of the PHS Act (42 U.S.C. 262(k))’.
This revised draft guidance replaces the draft guidance for industry Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products: Questions and Answers (February 2020) [3]. Changes from the 2020 draft guidance include additional recommendations and an example for interchangeable biosimilar products. In addition, editorial changes were made to improve clarity [1]. The Draft Biosimilar Promotion Guidance also serves as a final step to accomplish FDA’s goals from its 2018 Biosimilars Action Plan [2].
Overall, the revised draft guidance has five key messages about promotional communications for biologicals. These include:
- Claims or studies referenced in promotional communications should be connected to the product for which that specific information applies.
- Promotional communications should not imply that reference products are superior to their biosimilars.
- Promotional communications should not imply that interchangeable biosimilars are clinically distinct from other biosimilars.
- Promotional communications for biosimilars that present information from the studies conducted to support licensure of the reference product that is reflected in both the reference product and biosimilar product’s labeling should refer to the biosimilar product’s labeling.
- Promotional communications can include data or information about a biosimilar product that is not specifically included in the product’s labeling but is consistent with the FDA-approved labeling for that product.
This latest draft guidance follows other recent advances in clarifying expectations for biosimilar and interchangeable labeling and promotion, including FDA’s 2023 draft guidance entitled ‘Labeling for Biosimilar and Interchangeable Biosimilar Products’ [3].
FDA has released the draft for a comment period of 60 days, i.e. until 25 June 2024. Comments can be submitted online at https://www.regulations.gov/docket/FDA-2019-D-5473, or in written form, and can be mailed to Dockets Management, FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, USA. All written comments should reference the docket no. FDA-2019-D-5473.
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on labelling and advertising of biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 28]. Available from: www.gabionline.net/guidelines/FDA-issues-draft-guidance-on-labelling-and-advertising-of-biologicals
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars policy considerations in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 28]. Available from: www.gabionline.net/reports/Biosimilars-policy-considerations-in-the-US
3. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on biosimilars and interchangeable biosimilars labelling [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 28]. Available from: www.gabionline.net/guidelines/fda-issues-draft-guidance-on-biosimilars-and-interchangeable-biosimilars-labelling
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