FDA Gives The Green Light to the First ‘Biosimilar’ Drug

The Food and Drug Administration (FDA) ushered in a new era of medicine, approving the first non-brand name version of a biological drug the could generate billions in savings for insurers, doctors and patients.

The FDA approved Zarxio, made by Novartis US-based unit Sandoz, the first biosimilar drug to win government approval in the country.

The FDA's decision was the first approval of a so-called biosimilar in the U.S., a move set in motion in 2010 by Affordable Care Act provisions designed to cut the cost of biologics to patients.

Unlike generic drugs, which are chemically identical to brand-name drugs, biological products are generally derived from a living organism, including humans, animals and yeast.

"Biosimilars will provide access to important therapies for patients who need them," FDA Commissioner Dr. Margaret A. Hamburg said in a press statement.

The FDA had to devise a new approval process for biosimilar drugs, which is why it's taken so long for any to be approved.

"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.