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Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.
After many legal proceedings surrounding the first FDA-approved biosimilar, Zarxio officially launched commercially on Sept. 3, 2015.
Sandoz announced on Sept. 3, 2015 that despite the barriers erected by competitor Amgen, Sandoz officially launched Zarxio (filgrastim-sndz), its biologic version of Amgen’s neutropenia medication Neupogen (filgrastim). To complement the drug launch, Sandoz is also launching Sandoz One Source, a patient services center providing support for and information on the medication.
The announcement follows the release of FDA draft guidance on the naming of biosimilars, which proposed that each biologic have a core name plus a suffix to create a proper name. In the case of Zarxio, trial data demonstrated enough similarity between the biosimilar and the reference product to warrant extrapolation of the use of Zarxio to five indications associated with the reference product. FDA said in the draft guidance that the naming convention for related biological products that do not share all of the same indications as their reference products may differ from that of the proposed naming conventions for biosimilars that have all of the same indications as an innovator product.
Zarxio will be offered at a 15% discount from the the price of Amgen's Neupogen in the United States, although in Europe, the discount ranges from 20-30%, according to Reuters.