The FDA Oncologic Drugs Advisory Committee unanimously recommended approval
of Sandoz’s EP2006, a biosimilar for filgrastim (Neupogen). EP2006 is a
recombinant granulocyte colony-stimulating factor used to boost white
blood cells after cancer treatments
that deplete these necessary infection-fighting cells. If FDA-approved,
this would be the first true biosimilar in the U.S. and would have a
brand name of Zarxio. The FDA noted in their briefs
that EP2006 was “highly similar” to the brand biologic and had “no
clinically meaningful differences between the proposed product and the
reference product in terms of safety, purity, and potency”. The FDA
stated that “robust” pharmacokinetic and pharmacodynamic comparative
studies supported biosimilarity with the original filgrastim. Legal
action over patent protection may still interfere with a launch any time soon.
Biosimilars are just that; similar because they do not have to be exact
copies of the active ingredient, as with small-molecule drugs. The Biologics Price Competition and Innovation Act of 2009
(the BPCI Act) allowed the creation of an abbreviated licensure pathway
for biological products that are shown to be interchangeable with an
already FDA-approved biological product. Under the new law, a biological
product may be demonstrated to be “biosimilar” if data show that the
product is “highly similar” to an already-approved biological product.
Several biologics have already lost patent protection in Europe. An
established
legal pathway for biosimilars has been in the European Union since 2005.
Several biosimilars,
including somatropins, filgrastims, and epoetins, have been licensed and
marketed in the European Union (EU). Biologics that have already
expired in Europe include Neulasta (pegfilgrastim), Remicade (infliximab), Mabthera (rituximab, known as Rituxan in the U.S.), and Lovenox (enoxaparin).
Other top biologics facing future patent expiration include Humira (2018), Enbrel (2015), and Avastin
(2019), all well-known brands in the U.S. According to IMS, the
biologics market accounts for 27% of the pharmaceutical sales in Europe
and is growing at 5.5% vs. total market growth of 1.9% between 2012 and
2013.
France was the first EU member-state to initiate automatic pharmacist substitution for biosimilars in February 2014.
This site is for information on the various Chemo treatments and Stem Cell Therapies since 1992. This journey became bitter sweet in 2014, with the passing of my beautiful and dear wife. Sherry, had fought Non - Hodgkins Lymphoma(NHL) since 1990, in and out of remissions time and time again. From T-Cell therapies(1990's) to Dual Cord Blood Transplant(2014), she was in Clinical Trials over the years. This site is for informational purpose only and is not to promote the use of certain therapies.
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