PURPOSE: This multicenter, randomized, double-blind, active-control study was designed to determine whether a single subcutaneous injection of pegfilgrastim (SD/01, sustained-duration filgrastim; 100 ...
Sandoz is the first company to receive approval of a biosimilar in the US through the new FDA biosimilars pathway established under BPCIA Zarxio is approved for all indications included in the ...
On February 17, 2026, the U.S. Food and Drug Administration (FDA) approved FILKRI (filgrastim-laha), a biosimilar to Amgen’s NEUPOGEN (filgrastim). FILKRI was developed by Accord BioPharma, the U.S.
Filgrastim alone and sequential sargramostim and filgrastim have been shown to be more effective than sargramostim alone in the mobilization of CD34 + cells after myelosuppressive chemotherapy (MC).
Mantle-cell lymphomas have more widespread disease and a slower response to chemotherapy compared with follicle-center lymphomas: results of a prospective comparative analysis of the German Low-Grade ...
This report suggests that safe and effective mobilization can be achieved in a patient with prior radiotherapy and radioimmunotherapy for non-Hodgkin's lymphoma with the combination of pegylated ...
The digital press release with multimedia content can be accessed here: Holzkirchen, September 3, 2015 - Sandoz, a Novartis company, announced today that Zarxio(TM) (filgrastim-sndz) is now available ...
The US Food and Drug Administration (FDA) has expanded the indication for tbo-filgrastim (Granix, Teva), now allowing it to be self-administered by patients and their caregivers. Tbo-filgrastim, a ...
Novartis’ (NVS) generic arm, Sandoz, announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of its biosimilar version of ...
Although previous work has found lower costs for biosimilar filgrastim compared with reference filgrastim, this study found that site of care can change this calculus, reducing savings. Objectives: ...
A biosimilar version of filgrastim (EP2006, Sandoz/Novartis) has today been recommended for approval in the United States. The new product is like a generic version of the brand-name filgrastim, ...
The digital press release with multimedia content can be accessed here: Holzkirchen, September 3, 2015-Sandoz, a Novartis company, announced today that Zarxio(TM) (filgrastim-sndz) is now available in ...