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 ...

Novartis ($NVS) will be the first to hit U.S. shores with a copy of a blockbuster biotech drug, winning FDA approval for its take on Amgen's ($AMGN) Neupogen and ...

Gary Lyman, MD, MPH, an oncologist and hematologist, compares the uptake of filgrastim biosimlars with pegfilgrastim biosimilars. Gary Lyman, MD, MPH, is an oncologist, hematologist, and public health ...

On January 7, 2015, Sandoz, the generics wing of Novartis, announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended its biosimilar filgrastim (EP2006) for approval in the ...

Sandoz announced today that Sandoz Japan has received marketing authorization approval for its biosimilar filgrastim (Kyowa Hakko Kirin's GRAN®). The product, which will be marketed as Filgrastim BS ...

Update March 8, 2015: On March 6th the FDA approved this drug for sale in the U.S. with a new brand name, Zarxio. There’s big news from the FDA today with implications not just for the pharmaceutical ...