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First U.S. biosimilar just a step away from approval

By Mari Serebrov, Washington Editor

The FDA is a stone’s throw away from approving its first official biosimilar – a filgrastim follow-on developed by Sandoz International GmbH.

Sandoz reported today that the FDA has accepted its 351(k) biologics license application (BLA) for its biosimilar of Amgen Inc.’s Neupogen, a granulocyte-colony stimulating factor (G-CSF) used to treat neutropenia that came off patent last year. It’s the first biosimilar BLA the agency has accepted.

Meanwhile, Sandoz’s filgrastim has been making ripples globally for the past six years. Marketed as Zarzio in more than 40 countries, it was approved in the EU in 2009 and received approval earlier this year in Japan.

While Zarzio could be the first biosimilar approved in the U.S., it is one of 19 approved in the EU and the sixth to hit the Japanese market. So far, eight filgrastim biosimilars have been approved in the EU and five in Japan. (Some of those are the same product, but they are being marketed by more than one company and under different names.)

If it is approved in the U.S., Sandoz’s biosimilar would compete with Teva Pharmaceutical Industries Ltd.’s Granix (tbo-filgrastim), which was approved as a 351(a) BLA in 2012 and launched late last year, as well as Neupogen. It also will compete with Amgen’s Neulasta, a pegylated filgrastim that loses patent protection in both the EU and U.S. next year.

Despite the crowded market, Zarzio is the No. 1 biosimilar filgrastim globally and is the leading daily G-CSF in Europe with 30 percent volume market share, according to Sandoz, a Novartis Group company.