FDA updates guidance on promotional labeling and advertising of biosimilars

The US Food and Drug Administration (FDA) has published revised guidance on promotional labeling and advertising for prescription biosimilar drugs and their reference products.

The agency issued the draft guidance – Promotional labeling and advertising considerations for prescription biological reference products, biosimilar products, and interchangeable biosimilar products: Questions and answers – on 24 April and will accept comments through 25 June.

The document was designed to address industry questions about the promotion of reference prescription drugs, biosimilars and interchangeable products licensed under the Public Health Service Act, and to satisfy a requirement of the Biosimilar User Fee Amendments of 2022 (BsUFA III) for new guidance. (RELATED: BsUFA III commitment letter details FDA, industry goals for biosimilars program, Regulatory Focus 21 September 2021). It replaces 2020 draft guidance titled Promotional labeling and advertising considerations for prescription biological reference and biosimilar products: Questions and Answers.

Changes from the 2020 draft guidance include additional recommendations and an example of application for interchangeable biosimilar products; there were also some editorial adjustments.

“Among other things, prescription drug promotional communications must be truthful and non-misleading about the drug’s safety and effectiveness, and promotional communications must convey information about a drug’s effectiveness and its risks in a balanced manner and reveal material facts about the drug,” FDA wrote in the new guidance.

How to reference clinical data

The guidance notes that biosimilarity means a biological product is highly similar to a reference product, though there may be minor differences in clinically inactive components.

To meet the standard for interchangeability, where a product can be exchanged automatically without involving the prescriber, an applicant must demonstrate biosimilarity and prove the biologic has the same clinical results as the reference product in any given patient with no greater safety risks or diminished efficacy if there was a switch.

The quality and compliance of promotional communications is based on how information is presented, the type and quality of data included, and how disclosures are handled. Promotional references to studies of biosimilars should reflect FDA-approved labeling for the biosimilar products. Biosimilar product labeling typically includes relevant data and information on licensed conditions from the reference product’s FDA-approved label.

“FDA regulations also require that applicants promptly revise promotional labeling and advertising for their biological products upon certain changes to the FDA-approved labeling, including changes to risk information in the FDA-approved labeling,” the agency wrote.

Companies that want to cite supportive safety or effectiveness data not included in FDA-approved labeling should refer to FDA’s 2018 guidance Medical product communications that are consistent with the FDA-required labeling: Questions and answers. Also, communications must be compliant with statutory and regulatory requirements.

Be cautious with comparisons

FDA advised caution when comparing reference products and biosimilars. There might be variations in safety and efficacy results in studies aimed at proving biosimilarity, but that doesn’t mean they are clinically meaningful.

“In some cases, presenting otherwise accurate information about a reference product or about a biosimilar product could contribute to a misleading presentation when provided in a comparative context,” the guidance notes.

Comparing the number of indications could give the wrong impression that a biosimilar is less safe or effective if it has fewer approved uses.

“Representations or suggestions in promotional communications for the reference product that the biosimilar product is less safe or less effective than the reference product in any of the indications licensed for the biosimilar product because the licensure pathway for the biosimilar product differs from that for the reference product also would be misleading,” the guidance states.

Illustrating with examples

The draft guidance includes examples with fictional products to illustrate acceptable and unacceptable promotional language. The agency said it would be comfortable with this scenario, for example:

A firm is developing promotional communications for its biosimilar product called Nexsymeo. Promotional communications include the route of administration, dosage form, and strength described in Nexsymeo’s FDA-approved labeling and a claim that Nexsymeo has the same route of administration, dosage form, and strength as Junexant in the conditions of use for which both products are licensed. This claim is supported by Nexsymeo’s licensure as a biosimilar to Junexant, showing that the route of administration, dosage form, and strength are the same. Promotional communications also reflect interchangeability, which is supported by data in the biosimilar license application.

In contrast, FDA provided this scenario as one it would take issue with:

Promotional communications for Junexant state that in a clinical study, patients on Junexant experienced a numerically higher overall response rate than patients on Nexsymeo. The basis for the statement is a comparative clinical study that supported a demonstration of no clinically meaningful differences in terms of safety, purity, and potency between the reference product and the biosimilar. Although the statement is accurate, the difference in response rates was not statistically significant and the study design and other context were not provided.

As part of postmarketing requirements, companies are required to submit promotional materials for reference and biosimilar products to FDA at the time of dissemination, but they also have the option of voluntarily sending communications to FDA for feedback prior to publication.

FDA updates guidance on promotional labeling and advertising of biosimilars

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