July 24 U.S. regulators have accepted an
application by Sandoz - the generics arm of Novartis -
seeking approval for a copycat version of Amgen's drug
Neupogen, or filgrastim, for patients with low white blood cell
The Food and Drug Administration's decision to accept the
filing under a new pathway for so-called biosimilar drugs marks
a milestone in the rollout of cheaper copies of injectable
biotech medicines in the United States.
Sandoz said on Thursday that overcoming the first hurdle in
the approval process was an important step in increasing U.S.
patient access to such treatments.
The generics company already sells a biosimilar version of
Amgen's drug in more than 40 other countries, but the United
States has been slower than other markets to establish a
regulatory framework for biosimilars.
Because biotech drugs are made from living cells it is
impossible to manufacture exact copies, as happens with simple
chemical medicines, so regulators have had to devise approval
processes for products that are similar enough to do the job.
Filgrastim is used to reduce the rate of infections in
cancer patients undergoing chemotherapy, which often knocks out
their white blood cells, giving rise to a condition known as
"As they've done in Europe and other highly-regulated
markets around the world, biosimilars are poised to increase
U.S. patient access to affordable, high-quality biologics, while
reducing the financial burden on payers and the overall
healthcare system," said Mark McCamish, head of
biopharmaceutical and oncology injectables development at
Sandoz is the global leader in biosimilars, claiming a more
than 50 percent share of the market.
(Reporting by Ben Hirschler; Editing by Pravin Char)