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Erythropoetin copycat may get
European nod
Sandoz’ epoetin alpha could well
be 2nd biosimilar approved.
June 26, 2007
Low-cost version of one of the
largest selling anaemia drug may be
available in the European markets soon
European Union regulators supporting
the approval of a biosimilar version
of epoetin alfa, according to the
makers of the drug Sandoz. The company
said it has received a positive
opinion the regulators. If approved it
will be the second generic biologic
product to be approved in the European
region.
Since there is no consensus of copycat
versions of biological drugs anywhere
else in the world, Sandoz said the
approval would be a great achievement
and an important milestone in its
efforts to bring follow-on biological
medicines to patients.
Biologic drugs are complex proteins
derived through biotech routes. Unlike
their chemical counterparts they aim
to tackle disease and conditions as a
``natural, functional protein’’so they
are also called therapeutic proteins.
Bio therapeutics are even considered
the next wave or even the future of
modern medicine.
However, a regulatory pathway for
approving generic versions of
biotech-derived drugs in similar line
with that of their chemical cousins is
yet to evolve.
Sandoz was the first company to get
European approval for such a medicine,
the human growth hormone Omnitrope,
while US approval was granted in May
2006.
More than 250,000 patients in Europe
are estimated to be treated with
epoetin alfa, which is marketed under
various brand names, and similar
medicines to regulate the formation of
red blood cells. Worldwide annual
sales are estimated at more than USD 7
billion, including USD 600 million in
Europe.
The Committee on Medicinal Products
for Human Use (CHMP), which reviews
medicines scientifically in the
European Union, has now for the second
time issued a positive opinion for a
Sandoz biosimilar. In a
precedent-setting decision in April
2006,
The European Commission will now
decide on granting approval for this
biosimilar developed by Sandoz.
The positive opinion is another
important milestone for Sandoz as we
lead the way to bring high-quality and
cost-effective biosimilars to the
market following the expiry of
patents, noted Andreas Rummelt, CEO of
Sandoz in a press statement.
"We look forward to receiving European
Commission approval for this medicine
and providing patients and healthcare
payors a high quality treatment that
will improve access for patients and
also contribute significant savings to
healthcare budgets. We are committed
to further developing these types of
medicines and have several projects in
the pipeline," Rummelt said.
The CHMP recommendation supports the
use of epoetin alfa for indications
approved for the reference product at
the time of the Sandoz application for
EU approval. These include the use in
treating patients with renal anemia as
well as those receiving chemotherapy,
and specifically excludes the
subcutaneous administration for
patients with chronic kidney disease
and the use to increase the yield of
autologous blood from patients in a
predonation programme.
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