FDA Drafts Rules for Fair Biosimilar Promotion

The FDA's attempts to level the playing field for biosimilars and reference products continue to be a work in progress.

In draft biosimilar guidance this spring, the FDA chose to focus on what does and does not constitute fair and acceptable promotion for biosimilars. The drug-approving body has stated in the past that biosimilar- and reference-product companies trying to one-up one another by implying, without justification, that their products are superior in some way has been a problem.

For example, in 2021 the FDA slapped Amgen on the wrist for promotions suggesting that use of the company’s Onpro auto injector device for administration of Neulasta (pegfilgrastim) resulted in a substantially lower risk of febrile neutropenia versus use of a prefilled syringe, which was standard for a competing biosimilar product.

The FDA said there were so many limitations to the underlying comparison study that the superiority claim had no merit.

In its updated draft guidance, the FDA concludes that promotional materials that suggest a biosimilar or reference product is superior “are likely to be false or misleading.” Therefore, the FDA is advising companies to avoid making these types of comparisons.

The FDA based this guidance on the fact that when it approves a biosimilar for use, it has already made the determination that there are “no clinically meaningful differences” between the biosimilar and the reference product.

The FDA said that in promotional communications, it would be OK to describe such things as a biologic’s route of administration, dosage form, and strength, as well as any clinical study used as the basis for the FDA's approval.

However, the FDA advised biologics companies to tread very carefully when suggesting clinically superior results for one biologic compared with another because relevant clinical findings may not be statistically significant or important context may be left out, such as study design.

The FDA said it was also adamant that companies in no way suggest that interchangeable biologics are superior to simple biosimilars.

This last point was underscored by Sarah Yim, MD, FDA director of the Office of New Drugs, Office Of Therapeutic Biologics and Biosimilars, in an earlier statement: “Both biosimilars and interchangeable biosimilars must meet the same high standard of biosimilarity for FDA approval, and both are as safe and effective as the reference product,” she wrote.

In separate draft guidance late last year, the FDA recommended that biosimilar product labels do not refer to “interchangeability,” a designation indicating the FDA approves allowing pharmacists to automatically dispense biosimilars to patients who have been prescribed reference products by their doctors.

The FDA decided that pharmacists can use the Purple Book of biologics information to look up whether a biosimilar is interchangeable or not, and they don’t need that information on the product label.

The FDA decided, against mixed opinion in the medical/industrial field, that information about interchangeability has no place being on a product label because all biosimilars are, in fact, highly similar to their reference products, and doctors and patients should have no qualms about using them for an equivalent medical outcome.