Novartis: Sandoz Gets EU Approval For Generic Neupogen
February 13 2009 - 1:45AM
Dow Jones News
Swiss drugmaker Novartis AG (NVS) said Friday its generics unit
Sandoz has received final approval in the EU for its third
biosimilar, filgrastim, paving the way for this important oncology
medicine to be made available to patients across the European
Union.
Filgrastim is a biosimilar of Amgen (AMGN) drug Neupogen.
Filgrastim is indicated for the treatment of neutropenia, a
condition characterized by a lack of neutrophils - one of the most
common types of white blood cells - whose role is to fight
infection in the body. Neutropenia is often associated with
chemotherapy or bone marrow transplants, as well as advanced HIV
infections. Filgrastim is a natural protein produced commercially
by recombinant DNA technology, which stimulates production of white
blood cells.
The Sandoz product is approved for the same range of indications
as the reference product, Neupogen and offers patients comparable
quality, safety and efficacy combined with greater
cost-effectiveness. The novel Sandoz filgrastim needlestick
protection device decreases the risks of injury and exposure to
blood-born infection, thus contributing significantly to protecting
health professionals.
Sandoz CEO Jeff George says: "As the pioneer of biosimilars and
a company with a global reputation for offering high quality
medicines at affordable prices to patients and payors worldwide,
Sandoz is looking forward to providing this important new
cost-effective option for oncology patients.
"Filgrastim particularly helps patients receiving chemotherapy
to increase their neutrophil counts, meaning they can better avoid
the risk of the serious life threatening infections that so often
force clinicians to change their optimal therapeutic chemotherapy
regimen, dose or schedule."
Sandoz is the only company with marketing authorization for more
than one biosimilar medicine. In a precedent-setting decision in
April 2006, Sandoz received the first-ever EU approval for a
biosimilar medicine, human growth hormone Omnitrope. Binocrit /
Epoetin alfa Hexal, the first follow-on erythropoetin and the first
complex (glycoprotein) biosimilar, was approved in the EU in August
2007 and launched the same year. Sandoz has a comprehensive
biopharmaceuticals pipeline, with numerous projects at various
stages of development.
The European Commission approval followed a positive opinion
issued in November by the European Medicines Agency's Committee on
Medicinal Products for Human Use (CHMP), which provides scientific
reviews of medicines for the Commission.