Has anyone tried GRASPOFIU (subsitute of NEULASTA OR NEUPOGEN)

peachapple

Hi,

Wonder if anyone has tried this relatively new medication (was told that it was approved for us in Canada in April 2016). My husband's insurance does not cover both Neulasta or Neupogen and my own will likely cover two injections while I need six for my six cycles of chemo.

I also wonder the benefits of these kinds of medications, do they really help relieve the side effects of chemo??

BTW, I will start my chemo next week. Hope I will stay strong and positive for next couple of months.

Irene

BarredOwl

Hi peachapple:

I think you mean GRASTOFIL, which was recently approved by Health Canada and is manufactured by Apotex, Inc.

According to this Health Canada entry, GRASTOFIL is a "Subsequent Entry Biologic" form, or essentially a "biosimilar", of NEUOPOGEN (filgrastim).

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/rds-sdr/drug-med/rds-sdr-grastofil-156897-eng.php

GRASTOFIL also appears to have been approved as a "biosimilar" by the European Medicines Agency:

EMA EMEA database entry

In the US, it looks like Apotex has filed an application for approval of GRASTOFIL as a "biosimilar", but the application is still pending:

http://www.apotex.com/global/about/press/20150217-2.asp

In the US, there are three manufacturers of filgrastim, a biosimiliar of filgrastim, and a second filgrastim. The approval dates below were taken from the latest versions of the FDA labels available on-line:

(1) NEUPOGEN (filgrastim) - Initial US Approval 1991 - Original Reference Product

(2) ZARXIO (filgrastim-sndz) - Initial U.S. Approval: 2015 - Approved as a "Biosimilar"

http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm436648.htm

(3) GRANIX (TBO-filgrastim) - Initial U.S. Approval: 2012 - Full license application (not as a biosimilar)

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317392.htm

NEULASTA (PEG-Filgrastim), which is a form of filgrastim modified by the attachment of a PEG molecule (a covalent conjugate of recombinant methionyl human G-CSF (filgrastim) and monomethoxypolyethylene glycol ("PEG")), appears to be available from Amgen only in the US:

(1) NEULASTA (PEG-Filgrastim) - Initial U.S. Approval: 2002

Hopefully, more people will come along who may have received GRASTOFIL or who have had experience with some of the other biologics or biosimilar products listed above.

BarredOwl