FDA Recommends Approval of Sandoz’s Biosimilar Drug, a First 01/07/2015Posted by Morse, Barnes-Brown Pendleton in Client News, Life Sciences, Medical Devices.
Tags: Amgen, biosimilars, FDA, Sandoz
By: David Fazzolare
On January 5, 2015, the US Food and Drug Administration’s (“FDA’s”) Oncologic Drugs Advisory Committee (the “Committee”) announced its recommendation that the FDA approve Sandoz Inc.’s application to market Zarxio® (EP2006), a biosimilar version of Amgen, Inc.’s Neupogen® drug. The Committee explained its recommendation in a 62-page, publicly-issued briefing document. Zarxio® is the first drug reviewed by the Committee under new biosimilars provisions enacted as part of the Patient Protection and Affordable Care Act. The Committee’s recommendation is therefore a key step forward not only for Zarxio®, but also for implementation of the new biosimilars provisions (known as the Biologics Price Competition and Innovation Act of 2009, or “BPCIA”).
Sandoz is not yet seeking interchangeability status for Zarxio®, a designation which allows pharmacists to substitute biosimilars in place of prescribed reference biologics—i.e., Zarxio® in place of Neupogen®. Sandoz told the Committee it plans to file for interchangeability only after Zarxio® is fully approved as a biosimilar.
The Committee’s recommendation, while a milestone for the drug and the FDA, does not automatically clear the way for approval of Zarxio®. The Committee noted that the lack of comparative data available left some “residual uncertainty about whether ADA [anti-drug antibodies] incidence is similar in subjects administered [Zarxio®] and … Neupogen®.” On January 7, 2015, the FDA will take testimony from experts, who may weigh in on this issue, and provide their own recommendations as to whether the FDA should approve Zarxio® as a Neupogen® biosimilar. The FDA will then undertake a full review of Zarxio®. In the background is Amgen’s pending federal lawsuit against Sandoz, brought on October 24, 2014, which alleges Sandoz’s conduct violated the procedures required by the BPCIA. Amgen also submitted a citizen’s petition to the FDA on October 29, 2014, asking that the FDA require biosimilar applicants to fully comply with all BPCIA procedures. How the Committee’s recommendation will affect these filings remains unclear.
For more information, please contact David Fazzolare.