John Klimek, senior vice president for standards and industry information technology at NCPDP, addressed the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and Oncologic Drugs Advisory Committee (ODAC) meeting that met to review and make a recommendation on Sandoz’s filgrastim, a cancer treatment that’s a biosimilar version of Amgen’s Neupogen. ODAC unanimously urged approval of filgrastim, and the medication could receive final FDA approval this year.
Klimek spoke about the possible patient safety risks involved with deviating from using a different nonproprietary name than the innovator product for biosimilars. On behalf of NCPDP, he strongly urged the FDA to give biosimilars the same nonproprietary names as the innovator product to support the safe and effective use of biosimilars, citing how the drug compendia compile data, which is then interfaced for specific downstream needs in retail pharmacy, hospital or other health care settings.
“By maintaining a high integrity, unambiguous standards-driven system, we can reinforce existing naming standards designed to support the safe and effective use of all medicines — including biosimilars — in the interests of all stakeholders but, most importantly, patients,” Klimek explained.