FDA approves first biosimilar--but don't look for it on pharmacy shelves yet

Following a unanimous approval by a review panel in January, FDA has approved the commercial distribution of the biosimilar form of filgrastim, aka Amgen’s Neuprogen. Sandoz’ press release, issued on the same day as FDA’s, doesn’t say anything about a distribution timetable, and a Reuters report says that Amgen is suing to block the sale in the US; a decision on a preliminary injunction is expected in the next couple weeks. That article also puts global filgrastim sales at around $1.2 billion worldwide; Sandoz has been marketing its biosimilar for several years already, as Zarzio.

In the US, if the Amgen suit is resolved favorably for Sandoz, the company intends to market it as Zarxio. However, in the interim, it will be known as figrastim-sndz, which FDA says is a “placeholder nonproprietary name” which “should not be viewed as reflective of the agency’s decision on a comprehensive naming policy for biosimilar and other biological products.” FDA also noted that Zarxio has been approved as a “biosimilar” and not as an “interchangeable product” (the distinction has to do with the nature of the clinical data presented upon review; only an “interchangeable” can be substituted for the reference product without the intervention of a prescriber.) FDA is hoping to issue guidance on this controversial aspect of biosimilar commercialization in the near future.

Sandoz filed for review of Zarxio last summer, under the section 351(k) abbreviated licensure pathway, which became law when the Biologics Price Competition and Innovation Act was passed as part of the Affordable Care Act in 2010. As Sandoz noted at the time, Zarzio has been approved in 60 countries worldwide, generating over 7.5 million patient-days of exposure.

“The FDA approval of Zarxio marks a significant milestone for the United States healthcare system and for patients who might suffer from neutropenia,” said Carol Lynch, global head of biopharmaceuticals & oncology injectables at Sandoz, in a statement. “As the global leader in biosimilars, we are honored to be the first company to successfully work with FDA to navigate the US biosimilar pathway and we look forward to making this high-quality biosimilar available to patients in the US.”