Overview
The US Food and Drug Administration (FDA) has finalized important guidance on the promotional labeling and advertising of reference listed drugs (RLDs), biosimilar products, and, crucially, interchangeable biosimilar products. The primary goal of this document is to ensure that all promotional communications about these products are accurate, truthful, and non-misleading. The publication fulfills a legal requirement (Biosimilar User Fee Amendments of 2022 – BsUFA III) and aims to address industry questions, establishing clear standards for presenting scientific data and information about interchangeability, a key concept for the adoption and success of the biosimilars market.
Introduction
The Need for Direction in the Era of Biosimilars
The biologics and biosimilars market is rapidly expanding and is fundamental to the sustainability of global healthcare systems, offering alternatives to high-cost therapies. However, the scientific complexity of these products—especially the distinction between “simple” biosimilars and interchangeable ones (those that can be substituted by a pharmacist without the prescriber’s intervention)—creates unique challenges in promotional communication.
The finalization of this guidance by the FDA represents a decisive regulatory step. It aims to curb misleading claims that could confuse healthcare professionals and patients, whether by minimizing the similarity between the biosimilar and the reference product or by unduly exaggerating the benefits of an interchangeable product. The document sets the rules of the game for advertising, applying to both original biologics (approved under section 351(a) of the PHS Act) and biosimilars and interchangeable products (approved under section 351(k)). The focus is absolute: the conveyed information must accurately reflect the data approved by the Agency.
The Format and Focus of the FDA's New Directives
The guidance is predominantly presented in a question-and-answer format, which facilitates consultation and practical application by Regulatory Affairs and Marketing firms. The questions address several crucial topics:
- General Requirements and Product Identification
The guidance details the general requirements for the content of promotional communications, regardless of the medium (including digital and print media). It advises companies on how they must correctly identify reference products and biosimilar products in their materials, ensuring that the regulatory status (biologic, biosimilar, or interchangeable) is clear to the audience.
- Use of Reference Product Data
A central point is the guidance on how companies should present information from studies that supported the licensure of the reference listed drug (RLD), especially when that information is included in the FDA-approved labeling for both the RLD and the biosimilar. The FDA seeks to prevent the strategic omission of this data in promotional materials from creating the incorrect impression that the biosimilar lacks the same scientific support.
- Non-Misleading Comparisons Between Biosimilars and Reference Products
The guidance pays special attention to the considerations firms must take when comparing a biosimilar to its reference product in their communications. The text added in Question 5 of the guidance is particularly clarifying and crucial for compliance.
Example of Misleading Claim (FDA’s Added Clarification): “While a determination of whether any presentation is misleading is necessarily fact specific. FDA recommends that firms consider this possibility carefully when developing their promotional communications. For example, FDA recommends that firms avoid presentations in promotional communications for a reference product that compare the number of indications for which the reference product is licensed to the number of indications for which the biosimilar product is licensed in a manner that creates the overall impression that the biosimilar product is less safe or less effective than the reference product because the biosimilar product is licensed for fewer indications than the reference product.”
This new clarification aims to prevent marketing tactics that use the difference in the number of approved indications (a biosimilar may have only a subset of the RLD’s indications) to insinuate clinical or safety inferiority.
Key Takeaways: Implications for Compliance
Universal Scope: The guidance’s recommendations apply “regardless of the medium of communication (e.g., paper, digital),” a clarification added from the April 2024 draft version. This reinforces the FDA’s vigilance over digital marketing and social media.
Appearance of Inferiority: The FDA is clearly focused on preventing the reference biologic industry from using factual information (like the number of indications) in a way that creates an overall misleading impression about the safety or effectiveness of biosimilars.
Legal Mandate: The publication of this guidance is not merely an Agency initiative but the fulfillment of a legal requirement stipulated in BsUFA III, underscoring the importance of transparency for US health policy.
Conclusion
The finalization of the FDA guidance on promotional labeling for biologics and biosimilars is a regulatory landmark intended to level the playing field and protect the integrity of scientific communication. For companies operating with GRP and interacting with the US market, this guide serves as an essential compliance manual.
From now on, the rule is clear: companies must be transparent, avoid comparisons that insinuate clinical inferiority without scientific basis, and ensure that interchangeability status is communicated accurately. The future of biosimilars depends on trust, and regulating advertising is fundamental to building it.
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References
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