Mylan and Novartis Continue to Push Back Against FDA’s Biologics Suffixes

Mylan and Novartis criticized the FDA’s use of arbitrary suffixes in a non-proprietary naming convention for biologics in comments about a Sept. 4 a public hearing aimed at promoting biosimilars and interchangeable products.

Mylan claimed that the agency’s new naming convention introduced in January 2017 isn’t necessary for pharmacovigilance, hurts the market’s uptake of biosimilars and should be removed.

The FDA’s final guidance on non-proprietary naming for biologics directs both reference products and biosimilars to share the same core name, with both products bearing a different four-letter suffix that is “devoid of meaning.”