On Friday, the Food and Drug Administration approved a biosimilar version of Amgen's Neupogen® (filgrastim) product for sale in the U.S. This is the first biosimilar to be approved under the ...

THOUSAND OAKS, Calif., Oct. 22, 2013 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that it has entered into a definitive agreement with F. Hoffmann-La Roche ("Roche") to acquire Roche's rights ...

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 ...

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, ...

Clinical data from randomized studies demonstrated that Filkri is highly similar to the reference product with no clinically meaningful differences in safety, pharmacokinetics, or immunogenicity. The ...

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 ...

Teva currently markets filgrastim in Europe under the trade name Tevagrastim ®, a biosimilar to Neupogen ®. Tbo-filgrastim was filed in the U.S. as a Biologics License Application (BLA) since a ...

Please provide your email address to receive an email when new articles are posted on . The use of biosimilar biologics filgrastim-sndz and tbo-filgrastim increased substantially among Medicare ...

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." ...

PISCATAWAY, N.J.--(BUSINESS WIRE)--U.S.-based Adello Biologics today announced that U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) ...