Following a recent move to ask Congress to eliminate the interchangeability designation for biosimilars, the FDA on Wednesday proposed updated guidance on the labeling and advertising of biologics and biosimilars.
The new draft offers requirements around the content of promotional communications, and it follows the thinking around eliminating interchangeability in several places, changing up language and lumping biosimilars and interchangeable biosimilars together.
The title changed from “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products” to “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products.”
Another example in explaining that FDA approval means healthcare professionals should be confident that the safety and efficacy of the drug is the same as the reference product, the new guidance changes “a biosimilar or an interchangeable product” to simply “the biosimilar product.”
An additional scenario also points up the lessened distinction. The new “Example 4” says the FDA would not allow claims of better safety and effectiveness by a biosimilar also licensed as an interchangeable over a drug licensed only as a biosimilar. If the interchangeable was promoted as superior to a biosimilar of the same biologic, the FDA would consider it misleading, according to the document.
The new guidance also took into consideration the initial comments from 13 organizations, including Johnson & Johnson, Pfizer and PhRMA filed on the 2020 guidance. The FDA is soliciting comments on the replacement guidance through June 25.