NEW YORK — In what is emerging as the latest battle over follow-on biologics, a new argument has emerged about what to call them, and supporters of biotechnology companies are the latest to take a shot.
Like their pharmaceutical counterparts, branded biotech drugs carry both a brand name and a generic chemical name, such as the autoimmune drug Enbrel, made by Amgen and Pfizer, known generically as etanercept. By law, generic pharmaceutical drugs are chemically identical to branded drugs and use the same generic names, and the companies wishing to make follow-on biologics, or biosimilars, want the same policy for their products.
But biotech companies say that because biosimilars are made from different cell lines from branded biologics, they are only similar rather than identical, and thus their generic names should be different, such as carrying a prefix.
Last week, six senators submitted a letter to Food and Drug Administration commissioner Margaret Hamburg expressing concerns over biosimilar naming, and the Biotechnology Industry Organization, a trade group representing biotech companies — which stand to lose billions in sales when biosimilars begin hitting the market and competing with their products — has said it "strongly opposes" using the same generic names for biosimilars and branded biologics, saying it will lead to confusion.
"Use of the same nonproprietary name suggests something that is not true for biosimilars — that they are the same as the innovator drugs they reference," a recent statement from BIO read. "When ultimately approved by the FDA, biosimilars will be similar to, but not the same as, their respective reference products."
By contrast, generic drug companies and their supporters say biosimilars and branded biologics have used the same generic names in Europe during the six years they have been available there, without any problems.