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.
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.[eap_ad_2]
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.
“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. (Reuters)[eap_ad_3]