March 11, 2020

Food and Drug Administration Issues Product Labeling, Advertising Draft Guidance for Prescription Biological Reference and Biosimilar Products

The Food and Drug Administration’s (FDA) recent draft guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products – Questions and Answers,” offers insight and examples as to how FDA will likely view promotional materials for reference products and their biosimilar counterparts.

Released February 3, 2020, the draft guidance in large part calls for reference and biosimilar product promotion to follow the same rules as any prescription drug promotion with regard to being truthful, non-misleading and fairly balanced in presentation of safety and efficacy. However, the guidance stresses that any information (even if truthful) that suggests or represents a licensed biosimilar is not highly similar to a reference product should not be included in promotional product labeling or advertising for these products.1

I. Naming Products in Promotional Materials

The draft guidance specifies that promotional materials should clearly and correctly identify the specific product(s) to which they refer. For example, it may be appropriate to use a biological product’s core name (i.e., the name for the component shared among a reference product and any related biological product, biosimilar product or interchangeable product) followed by the word “products” when conveying a risk that applies to both the biosimilar and the corresponding reference product. In contrast, descriptions of studies that involved another specific product (for example, a non-U.S.-licensed comparator product) should accurately identify that specific product. The draft guidance recommends using the same terminology that is found in FDA-approved labeling whenever possible.

II. Including Data in Promotional Materials for Biosimilars

The draft guidance notes that it may be appropriate to include data from studies in promotional materials for biosimilars. It separately addresses data in two broad categories: data that appears in FDA-approved labeling and data that does not. In general, the guidance recommends that companies refer to a product’s FDA-approved labeling when discussing data that appears in such labeling. However, it also recognizes that FDA-approved labeling generally does not include data or information from studies conducted to support a demonstration of biosimilarity. Such data must be presented in a way that is consistent with the FDA-approved labeling and be truthful and non-misleading. The draft guidance refers companies to FDA’s June 2018 guidance, “Medical Product Communications That Are Consistent With the FDA-Required Labeling – Questions and Answers” (the CFL guidance) for further guidance.

III. Comparisons Between Reference Products and Biosimilar Products

The draft guidance makes clear that promotional materials should not create an impression that there are clinically meaningful differences between the reference product and any biosimilar products.

Primarily, the guidance notes that any suggestions that a biosimilar product is less safe or effective than its reference product, or is not highly similar to it, “are likely to be false or misleading.” For example, the guidance deems “misleading” any suggestion that a biosimilar is less safe or effective because:

  1. It has been licensed for only a subset of the reference product’s indications.
  2. It received licensure for an indication based on extrapolation of data rather than direct study in that indication.
  3. It has not been licensed as an interchangeable product.
  4. It may or may not be identical to the reference product.

Similarly, the guidance also discusses ways in which promotional materials for biosimilar products might draw misleading comparisons. For example, it notes that representations that a biosimilar product is in any way superior to its reference product would be misleading. The guidance also cautions against suggesting that a biosimilar is identical to or interchangeable with a reference product, both of which would be misleading.


It is important for companies that promote biological products to know that it is not enough to ensure that promotional materials are factually truthful and accurate. The draft guidance suggests that FDA will view any attempt to denigrate a product’s designation as “biosimilar” as misleading. This admonition by FDA corresponds with a recently announced joint effort by FDA and the Federal Trade Commission (FTC) to deter anticompetitive business practices that are seen as a threat to expansion of the biosimilar market. Perhaps more interestingly, FDA will also view as misleading any attempt to oversell a biosimilar designation, e.g., by suggesting that a biosimilar product is interchangeable with the reference product.

FDA is receiving comments and suggestions regarding the draft guidance through April 2, 2020.

  1. 42 U.S.C. §262(i)(2)(B) provides that products may be designated “biosimilar” to a reference (i.e., brand-name) product if there are “no clinically meaningful differences” in terms of safety, purity or potency between the two, notwithstanding minor differences in clinically inactive components.

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