FDA Actions Could Deter Biosimilar Use: Activist
Citizens Against Government Waste (CAGW) president Tom Schatz says that FDA decisions on biosimilar labeling could “create obstacles in biosimilars by both sending a signal that they are not as safe or effective as their corresponding brand-name biologics, and raising questions about the two types of drugs that are not broached with respect to brand-name chemical drugs and their generic versions.” Writing in an online opinion piece for The Hill, Schatz specifically cites FDA’s decisions to date on nonproprietary names for biosimilars and requiring a biosimilarity statement in biosimilar labeling.
He writes that CAGW objected when FDA issued the “placeholder” nonproprietary name filgrastim-sndz for Sandoz’ Zarxio, a biosimilar to Amgen’s Neupogen (filgrastim). The organization said that the four-letter suffix was unnecessary under the Biologics Price Competition and Innovation Act. Rather than fix the problem, he says, FDA issued an 8/2015 draft guidance “that made nonproprietary names even more confusing for health professionals.” He says that guidance called for addition of non-meaningful and distinct four-letter suffixes attached to the nonproprietary names of both biosimilars and their branded biologics. Under that guidance, Zarxio’s nonproprietary name would be changed to filgrastim-bflm and Neupogen’s nonproprietary name would become filgrastim-jcwp.
“CAGW agreed with the Federal Trade Commission’s opinion that the final adoption of the draft guidance ‘could result in physicians incorrectly believing that biosimilars’ drug substances differ in clinically meaningful ways from their reference biologics’ drug substances, especially since differences in drug substance names have traditionally connoted meaningful differences in drug substances,’” Schatz writes.
He also takes on the portion of FDA’s March draft guidance on biosimilar labeling that requires a biosimilarity statement. “If the drug has been approved by FDA, it means that there are no clinically meaningful differences between the biosimilar and the brand-name biologic in terms of safety, purity, and potency,” Schatz writes. “There is absolutely no need to repeat that information with a comment on the label that the new product is approved to be a biosimilar to its respective brand-name biologic. This kind of information is not required in other pharmaceutical products that have been found to be therapeutically equivalent.”
Schatz concludes that with different nonproprietary names and superfluous information in labels, the use of biosimilars might be questioned by health professionals and patients, “negating the good work that has been accomplished in trying to catch up with other countries that have been utilizing biosimilars, with the same nonproprietary names, for many years.”