U.S. paves way for Novartis to copy Amgen biotech drug

[July 24, 2014]  (Reuters) - 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 counts.

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 neutropenia.

"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.

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)

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