On yesterday’s earnings call for Q4 2016, Amgen indicated that it is projecting its Neulasta® (pegfilgrastim) product to face biosimilar completion in the U.S. by the end of the year. According to ...

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 ...

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 ...

SAN DIEGO--(BUSINESS WIRE)-- Apricus Biosciences (“Apricus Bio”) (Nasdaq: APRI), backed by a revenue generating CRO business and seeking to leverage its multi-route NexACT ® drug delivery technology ...

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 ...

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 ...

The first biosimilar product in the United States has been approved by the US Food and Drug Administration, in a move described by the agency's director, Janet Woodcock, as a "significant milestone." ...

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 ...

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 ...