The US Food and Drug Administration (FDA) has given a green signal for the first non-brand name version of a biological drug. Called Zarxio, the drug enables patients to grow more white blood cells when they have been wiped out by chemotherapy.

Sandoz is the manufacturer of Zarxio, which is a low-cost copy, or biosimilar version, of Amgen's biologic drug Neupogen. The FDA approved Neupogen, generically known as filgrastim, in 1991.

There is no doubt that biological drugs have brought significant advances in medical science, which is evident from the transformation in cancer care and some other diseases, like juvenile arthritis. But high cost of such drugs has remained a big issue. This is the first time a non-brand name competitor has been given the approval by the FDA.

FDA Commissioner Dr. Margaret A. Hamburg said in a press statement that biosimilars will ensure that patients in need are able to access important therapies. A new approval process is something the FDA may want to look into for biosimilar drugs.

The agency was facing pressure from a law -- part of the Affordable Care Act -- to make biosimilars available because they are cheaper than brand-name drugs.

"As the global leader in biosimilars, we are honored to be the first company to successfully work with the FDA to navigate the U. S. biosimilar pathway, and we look forward to making this high-quality biosimilar available to patients in the U. S", Carol Lynch, the global head of biopharmaceuticals and oncology injectables at Sandoz, said in a press statement.

The FDA compares biosimilar drugs to the original drug and is required to show that the drugs have the same indications, mechanisms, and dosages. Manufacturers of biosimilars are also required to prove that the facilities used for the production of biosimilars are in line with FDA standards.