“… we are concerned about the FDA’s requirement to include a biosimilarity statement on biosimilar labeling. The biosimilarity statement is at best unnecessary. The FDA has never required any similar statement for products found to be therapeutically equivalent, and has not provided sufficient justification for its inclusion in biosimilar labeling. Moreover, the biosimilarity statement will be confusing to patients and providers who are unfamiliar with this type of unprecedented statement. This confusion could put biosimilar utilization, and savings, at risk.”
Consider generic drugs and information transparency. According to the FTC’s 1979 report on generic drug substitution, that agency concluded, “increased communication (as well as lower prices) may explain why most pharmacists report that product selection laws have had a positive effect on their relations with patients”
Safety and trust are exactly why transparency-in-labeling is needed. As Sumant Ramachandra, Senior Vice President & Chief Scientific Officer at Pfizer’s Hospira unit, has said, “Communications fosters confidence.”
And Geoffrey Eich (Executive Director, R&D Policy, Amgen) has asked:
Why not transparently label biosimilars to engender patient and physician confidence?
Why not ensure accurate patient medical records that clearly identify specific products?
Indeed, at a time when the FDA is considering a rule for the differential labeling of small molecule generics, why not transparency in biosimilar labeling?
It’s important to mention that the majority of the letter signatories are … payers.
Draw your own conclusions.