Biosimilar and Interchangeable Biosimilar Products – Considerations for Promotional Labeling and Marketing
Welcome back! We’ve been following the Food and Drug Administration (FDA) on their guidance for biosimilar and interchangeable biosimilar products. On 12/09/2025, the FDA released their “Questions and Answers (Q&A) Guidance for Industry for Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products”. This document provides guidance to all communication mediums (i.e., digital and print) on promotional labeling and advertising considerations for prescription biological reference products, biosimilar products, and interchangeable biosimilar products. The FDA centers on how manufacturers and marketers should communicate about these products while ensuring that information is accurate, truthful, and not misleading. Let’s summarize!
Section 351(k) of the Public Health Service (PHS) Act allows for an abbreviated licensure pathway for biosimilar products. “Biosimiliarity” means the product is highly similar to a reference product with no clinically meaningful differences in safety, purity, and potency. To meet the standard for “interchangeability”, there must be sufficient information to demonstrate biosimilarity and that the biological product can be expected to produce the same clinical result as the reference product in any patient and also that the risk and safety or diminished efficacy of alternating or switching between the use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch. Interchangeable biosimilars can be substituted for reference products without healthcare provider intervention [1] .
The Q&A goes on and touches on the general topics summarized below. In general, promotional communications must be truthful and non-misleading regarding safety and effectiveness as well as balance information about a drug’s effectiveness and risks which reveal material facts, and promotional materials must be revised promptly upon changes to FDA-approved labeling.
Identifying Reference and Biosimilar Products
Organizations must accurately identify reference and biosimilar products in promotional materials. Proper names, proprietary names, and core names should be used to prevent misinformation. Correct identification helps audiences understand which products are being discussed.
Presenting Information from Reference Product Studies Including Safety and Effectiveness Data
When using data from reference product studies, companies should refer to the biosimilar product’s FDA-approved labeling. The biosimilar’s labeling may include relevant data from the reference product’s studies. If a biosimilar is licensed for fewer conditions, only relevant data should be included in its labeling. It’s important that promotional materials align with FDA-approved labeling. Any data not included in the FDA-approved labeling must comply with regulatory and statutory requirements. Promotional materials should not mislead the safety or effectiveness of the biosimilar product; it also should not suggest any clinically meaningful differences between them. Claims of superiority or inferiority based on non-clinically meaningful differences are misleading, and information must be provided to avoid misleading impressions.
Additional Considerations and Postmarketing Reporting
Promotional materials should accurately reflect the licensure status of biosimilars. Organizations should avoid suggesting that biosimilars are less safe or effective due to their licensure pathways and also recognize that biological products may have minor differences without impacting safety or efficacy. Companies can voluntarily seek FDA feedback on promotional materials before they are disseminated by following the established process for submitting a draft promotional communication for FDA comment [2] . For postmarketing, companies must submit copies of their promotional materials to the FDA at the time of initial publication with a completed Form FDA 2253. This is required for all promotional labeling and advertising for drugs and biologics [3] .
So how does this impact the human cells, tissues, and cellular and tissue-based products (HCT/Ps) industry? HCT/Ps represent a distinct category within the FDA’s regulatory framework. While most biosimilars and interchangeable biosimilars are regulated as biological products under the PHS Act, HCT/Ps may be regulated either under Section 361 (as minimally manipulated products and homologous use), or as biological products under Section 351 depending on their characteristics and use. The FDA’s promotional labeling and advertising guidance for biosimilars has implications for HCT/Ps that are regulated as biological products where manufacturers must ensure that any promotional communications about biosimilar or interchangeable versions of their products adhere to the same principles outlined in the guidance.
Key Points
Any claims about biosimilarity or interchangeability must be scientifically substantiated and clearly presented.
Communication about product risks and benefits must be comprehensive and consistent with FDA-approved labeling requirements.
Comparative statements must not exaggerate differences or similarities between products.
This Q&A guidance on promotional labeling and marketing for biological refence products, biosimilars, and interchangeable biosimilars provides a framework for truthful, balanced, and compliant communications. As biosimilars and interchangeable biosimilars become more prevalent in the marketplace, industry stakeholders must ensure their promotional practices align with FDA expectations. Doing so not only supports regulatory compliance but also fosters trust among healthcare providers and patients!
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