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

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U.S. regulators have accepted an application by Sandoz – the generics arm of Novartis – seeking approval for a copycat version of Amgen’s Neupogen, or filgrastim, for low white blood cell counts.

The Food and Administration’s decision to accept the filing under a new pathway for so-called biosimilar drugs marks a milestone the rollout of cheaper copies of injectable biotech medicines the .

Sandoz said Thursday that overcoming the first hurdle the approval was an important step increasing U.S. access to such treatments.

The generics company already sells a biosimilar version of Amgen’s than 40 other countries, but the has been slower than other markets to establish a regulatory framework for biosimilars.[eap_ad_2]

Because biotech drugs are made from living cells it is impossible to manufacture exact copies, as happens 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 the rate of infections in cancer undergoing chemotherapy, which often knocks out 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. access to affordable, -quality biologics, while reducing the financial burden payers and the overall healthcare ,” said Mark McCamish, head of biopharmaceutical and oncology injectables development at Sandoz.

Sandoz is the global leader in biosimilars, claiming a than 50 percent share of the market. (Reuters)[eap_ad_3]