With the last legal hurdle removed, Sandoz wasted no time launching its Zarxio biosimilar of Amgen’s chemotherapy product Neupogen nationwide — offering the first U.S. biosimilar at 15 percent below the price of its reference product.
The Federal Circuit Court of Appeals cleared the way for the launch last week when it rejected Amgen’s eleventh-hour request for an emergency injunction. The company wanted the court to delay Zarxio’s launch until it acted on a request for a full court review of a three-judge panel’s ruling that biosimilars makers aren’t obligated to share information in their applications with the reference product manufacturer.
Sandoz set the wholesale acquisition cost for a 300 mcg syringe at $275.66 and a 480 mcg syringe at $438.98. Comparable doses of Neupogen (filgrastim) go for $324.30 and $516.45, respectively. The WAC cost does not take into account discounts, rebates and other price concessions.
Sandoz offered a similar 15 percent discount when it rolled out Zarxio in Europe in 2009. The current European discount is around 20 percent or 30 percent, according to a spokeswoman.
The FDA approved Zarxio (filgrastim-sndz) in March, sparking an immediate challenge by Amgen to block Neupogen competition.
There are currently four publicly disclosed biosimilar applications pending with the FDA: Apotex’s aBLAs against Amgen’s Neupogen and Neulasta (pegfilgrastim), Celltrion’s against Janssen’s Remicade (infliximab) and Hospira’s against Amgen and Janssen’s Retacrit/Procrit (epoetin alfa). — John Bechtel