Prime Therapeutics welcomes FDA's approval of first biosimilar in USA, but says more clarity is needed

Prime Therapeutics, a non-profit US pharmacy benefit manager serving more than 26 million members, has responded to the US Food and Drug Administration's approval of the first biosimilar to enter the US market.

The biosimilar in question, Zarxio (filgrastim-sndz), from Swiss pharma major Novartis’ (NOVN: VX) subsidiary Sandoz, was approved last Friday (The Pharma Letter March 6) and will compete with Amgen’s (Nasdaq: AMGN) Neupogen (filgrastim).

"Today's US Food and Drug Administration approval of Sandoz's Zarxio to treat neutropenia, a condition affecting about half of all cancer patients, is a major milestone in our country's journey to curb the escalating costs of specialty drugs," said Peter Wickersham, senior vice president for integrated care and specialty at Prime. "However, it's really only a first step, as we believe a robust market for biosimilars may be in jeopardy if regulators and lawmakers on federal and state levels adopt adverse regulations that create steep hurdles for biosimilar manufacturers,” he added."