FDA Panel Supports Sandoz’s Biosimilar Application on Neupogen

An FDA advisory committee has thrown its support behind the first publicly acknowledged biosimilar application in the United States.

Industry experts on the FDA’s oncologic drugs advisory committee voted 14-0 to recommend the agency approve Sandoz’s bid to produce its own version of Amgen's Neupogen (filgrastim), which Sandoz plans to market in the U.S. as Zarxio.

FDA staff had already given Sandoz’s application their own stamp of approval last week with a finding that the firm’s version was highly similar and showed no clinically meaningful differences to Amgen’s reference version.

The committee gave its recommendation in part because of the hundreds of thousands of European patients who have taken the biosimilar and have shown the same outcomes as Neupogen across millions of days of exposure. That data helped override lingering committee concerns with differences in the pharmacodynamic parameters presented in the application data.

CDER Director Janet Woodcock called the meeting a historic occasion, the culmination of years of work and the first of many meetings for different biosimilars.

Observers had expected the meeting to help set the tone for future FDA consideration of biosimilars. The agency is expected to continue dealing with applications on a case by case basis, initiating similar advisory committee meetings for each new proposed biosimilar for the foreseeable future.

Lingering over the meeting was the question that first drove Congress’s 2010 creation of a biosimilar approval pathway: whether or not biosimilars will lower costs and improve patient access.

Sandoz’s head of biopharmaceuticals, Mark McCamish, assured the committee that the biosimilar would cost less than the brand. However, the price may at times be at parity with the reference, he cautioned. Other factors, such as rebates, will ultimately drive down the cost to the end-payer patient or insurance provider, he said.

Committee member James Liebmann was not as confident with the cost-saving assessment. He specifically asked about pricing for the therapy and noted that while Sandoz’s biosimilar version, marketed as Zarzio in Europe, has created savings, European and U.S. drug costs are radically different, he said.

The committee heard the application as EP2006 because the brand name Zarxio, spelled with an “x” in the U.S., has not yet been approved by the FDA. The FDA heard the application as a biosimilar rather than on the higher regulatory burden of an interchangeable therapy. The difference in theory would be that interchangeables could be directly swapped from the prescribed reference therapy at the pharmacy, although that will depend on state-by-state substitution laws. — Bryan Koenig