Stakeholders urge FDA to strengthen guidance on biosimilars promotions, stop bad actors

Some stakeholders want the US Food and Drug Administration (FDA) to strengthen its draft guidance on promotional communications for biosimilars to prevent the spread of misleading information that could threaten to slow adoption of such products.

Biosimilars companies believe new draft guidance – Promotional labeling and advertising considerations for prescription biological reference products, biosimilar products, and interchangeable biosimilar products: Questions and answers – could go further to prevent misinformation in the industry. (RELATED: FDA updates guidance on promotional labeling and advertising of biosimilars, Regulatory Focus 26 April 2024)

Among other things, the new guidance, which replaces a draft from 2020, provides specific examples of acceptable and unacceptable language when making comparisons of reference prescription products, biosimilars and interchangeable biosimilars. As explained in the guidance, biosimilars are highly similar to a reference product, but they may have minor differences in clinically inactive components, while “interchangeable” means a product can be exchanged automatically without involving the healthcare prescriber.

“Misinformation has been a significant impediment to use of safe and effective lower priced biosimilars, and the revised guidance will help ensure that sponsors engage in truthful and non-misleading communications regarding biosimilars,” wrote the Biosimilar Council in comments, which were due to FDA by June 25.

The Biosimilars Council, which is part of the Association for Accessible Medicines (AAM), wrote that it appreciates that FDA made it clear there are no clinically meaningful differences between biosimilars and reference products and that biosimilars may be used by treatment-naïve and switched patients.

“Nevertheless, the guidance would benefit from an affirmative statement from FDA that interchangeability does not represent a higher standard or convey increased quality, safety, or efficacy than biosimilarity, and that a healthcare provider can be just as confident in prescribing a biosimilar as an interchangeable, regardless of whether the patient is new to treatment or is currently being treated with the reference product,” the Biosimilars Council wrote. “FDA staff have made similar statements in various contexts, but it would be helpful to include such a statement in the revised guidance.”

Samsung Bioepis, a Korean biosimilars maker, noted that references to the interchangeability can cause confusion and be misleading; prescribers can be confident of a biosimilar’s safety and effectiveness regardless of whether it has this designation. (RELATED: Biosimilars: FDA offers rationale for dropping interchangeability designations, Regulatory Focus 30 October 2023)

“The reason for the lack of the interchangeability designation by FDA may be wholly separate from the science, such as awaiting expiration of the first interchangeable biosimilar’s exclusivity period,” Samsung Bioepis wrote. “That does not make subsequent biosimilars in any way inferior as a regulatory matter, but currently they are often perceived that way.”

Misinformation that biosimilars lacking the interchangeability designation are inferior results in unfair competition, damages prospects for future biosimilars development, and denies patients access to more affordable biologics, the company suggested. Additional clarifications in the guidance could help combat widespread misinformation, according to Samsung Bioepis.

Statements in promotional materials can imply that a product is substandard in subtle ways. “The nuance can be subtle and yet the final context unambiguous,” Samsung Bioepis explained. For example, saying that no other product has been approved by the FDA as an interchangeable is factually accurate but can be misleading, the company noted. In this example, there could be a clarification added that while this is the only interchangeable product, other biosimilars can be switched by the prescriber with no change in safety or efficacy expected, the company proposed.

“So overall, while the draft guidance provides valuable recommendations in presenting data and information about reference products or biological products in these promotional communications to help ensure that they are accurate, truthful, and non-misleading, we ask FDA to go further,” Samsung Bioepis suggested. “For example, since there has been no apparent consequence for miscreants to date, FDA may also consider enforcing steps to correct and prevent repeated misinformation.”

The Biosimilars Forum concurred, stating that while it “strongly support[s]” the draft guidance, it believes the final version would be improved if it “explicitly stated that interchangeability does not represent a higher standard of FDA assessment or biosimilar safety, efficacy, or quality; that a designation of interchangeability does not explicitly or implicitly indicate that the interchangeable biosimilar is any more safe, effective, or quality-assured than a biosimilar to the same reference product; and that a healthcare provider can be just as confident prescribing a non-interchangeable biosimilar as an interchangeable one, regardless of whether the patient is new to treatment or is currently being treated with the reference product.

The Forum also called on FDA to strike a recommendation from the guidance that biosimilar sponsors identify the source of comparator products as “non-US-approved product” for products that relied on bridging data comparing the non-FDA-licensed version to the FDA-licensed reference product.

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Stakeholders urge FDA to strengthen guidance on biosimilars promotions, stop bad actors

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