BioRationality: FDA Issues New Guidance on Promotional Communications for Biosimilar Products

The FDA has released comprehensive guidance addressing promotional labeling and advertising considerations for prescription biological reference products, biosimilar products, and interchangeable biosimilar products. This December 2025 guidance provides critical clarification for manufacturers navigating the complex landscape of biosimilar marketing communications.¹

FDA's new guidance clarifies promotional practices for biosimilars, ensuring accurate marketing and preventing misleading claims in the competitive landscape. | Image credit: digicomphoto - stock.adobe.com

Core Regulatory Framework

The guidance underscores that all prescription biological products, whether reference products or biosimilars authorized under sections 351(a) or 351(k) of the Public Health Service Act, are required to adhere to the misbranding provisions stipulated in the Federal Food, Drug, and Cosmetic Act. Promotional communications must be accurate, not misleading, provide a balanced depiction of benefits and risks, and disclose all material facts pertaining to the products.

A fundamental principle underlying the guidance is the FDA's determination that licensed biosimilar products are highly similar to their reference products with no clinically meaningful differences in safety, purity, or potency. This scientific determination forms the basis for the FDA's recommendations on appropriate promotional practices.

Product Identification Requirements

The guidance stresses the importance of correctly and specifically identifying products in promotional materials. Biological products typically have three naming components: a proprietary (brand) name, a proper name (FDA-designated nonproprietary name), and a core name shared among related products. Firms must carefully evaluate each promotional communication to ensure accurate product identification, particularly when discussing risks that apply to both biosimilar and reference products or when presenting comparative information.

Presenting Clinical Data

A critical aspect of the guidance addresses how firms should present clinical data in biosimilar promotional materials. When including information from studies that supported the reference product's licensure—data that appears in both products' FDA-approved labeling—firms should reference the biosimilar product's labeling. This approach ensures consistency with FDA's determination that the biosimilar can rely on the reference product's clinical data through the abbreviated licensure pathway.

For data not included in the biosimilar's FDA-approved labeling, such as biosimilarity demonstration studies, companies may present this information provided it remains consistent with the approved labeling and complies with the FDA's standards for medical product communications. Such presentations must include appropriate context regarding study design, methodology, the study's role in biosimilarity assessment, and any material limitations.

Comparative Claims and Competitive Positioning

The guidance provides crucial direction on comparative promotional communications between biosimilar and reference products. FDA explicitly warns against representations suggesting clinically meaningful differences between approved biosimilar products and their reference products. Claims of superiority—whether suggesting the reference product is safer or more effective than the biosimilar, or vice versa—are likely to be considered false or misleading.

For example, promotional materials cannot appropriately claim greater efficacy for a biosimilar based on numerically higher response rates from a biosimilarity study if those differences weren't statistically significant or clinically meaningful. Similarly, suggesting a biosimilar is inferior because it wasn't directly studied in each indication, while the reference product was, would be misleading.

Interchangeability Considerations

The guidance addresses a particularly sensitive area: promotional communications regarding interchangeable designation. FDA clarifies that promotional materials should not suggest biosimilar products without an interchangeable designation are less safe or effective than those with such a designation. All biosimilar products, whether interchangeable or not, meet the same high standard of biosimilarity for approval.

Representations implying that patients currently treated with a reference product should not switch to a non-interchangeable biosimilar, or that healthcare providers should have safety concerns about prescribing non-interchangeable biosimilars, would be considered misleading.

Licensure Pathway Communications

A significant portion of the guidance addresses communications about different licensure pathways. Firms should avoid suggesting that biosimilar products are inferior because they followed an abbreviated licensure pathway rather than the whole development pathway of reference products. The guidance also cautions against misleading comparisons based on the number of approved indications, strengths, dosage forms, or routes of administration between biosimilar and reference products.

FDA recognizes that biological products naturally exhibit minor batch-to-batch variation without affecting safety, purity, or potency. Therefore, promotional communications suggesting biosimilars are inferior because they're not identical to reference products would be inaccurate and misleading.

Practical Examples and Implementation

The guidance provides concrete examples illustrating acceptable and unacceptable promotional practices. Acceptable communications might include claims that a biosimilar has the same route of administration, dosage form, and strength as the reference product for approved indications, or that healthcare providers can prescribe the biosimilar to both treatment-naïve and treatment-experienced patients.

Conversely, promotional materials that highlight numerical differences in response rates without disclosing lack of statistical significance, or that suggest interchangeable products are superior in safety and effectiveness to non-interchangeable biosimilars, would be considered misleading.

Regulatory Compliance Requirements

Firms seeking FDA feedback on promotional materials before dissemination should follow established procedures for submitting draft communications. Additionally, all promotional materials remain subject to postmarketing reporting requirements, requiring submission to the FDA at the time of initial dissemination along with Form FDA 2253.

Implications for Industry

This guidance represents the FDA's effort to ensure a level playing field in biosimilar marketing while maintaining scientific accuracy in promotional communications. By clarifying acceptable promotional practices, the FDA aims to prevent misleading comparisons that could undermine confidence among healthcare providers and patients in biosimilar products.

The guidance emphasizes that biosimilar products provide equivalent therapeutic benefits to reference products, thereby encouraging wider adoption of biosimilars while ensuring that promotional materials accurately represent the scientific rationale behind biosimilar approval. Manufacturers are advised to meticulously review their promotional strategies to ensure adherence to these comprehensive recommendations, especially when making comparative claims or addressing the biosimilar development process.

As biosimilar competition intensifies, this guidance provides essential guardrails to ensure that competitive positioning remains grounded in scientific evidence rather than creating artificial distinctions unsupported by clinical data. The ultimate goal is fostering an environment where biosimilars can compete effectively while maintaining the integrity of promotional communications in the biological products marketplace.

Reference

1. Promotional labeling and advertising considerations for prescription biological reference products, biosimilar products, and interchangeable biosimilar products. FDA. December 10, 2025. Accessed December 11, 2025. https://www.fda.gov/media/134862/download