Novartis wins first FDA approval of biosimilar drug

The United States opened the door to cheaper biotech drugs today, accepting a biosimilar cancer drug made by Swiss pharmaceutical giant Novartis.
The US Food and Drug Administration approved Zarxio, made by Novartis US-based unit Sandoz, the first biosimilar drug to win government approval in the country.
The FDA said Zarxio was highly similar in terms of safety and effectiveness to Amgen's Neupogen, a biotech drug used to treat low amounts of certain white blood cells that often follow cancer treatments such as chemotherapy.
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.

A biosimilar product, dubbed an "interchangeable", is a biological product that is approved based on evidence that it is highly similar to an already-approved biological product.
The breakthrough approval for Zarxio came in a speeded-up FDA process that is part of President Barack Obama's health-care reforms.

The Affordable Care Act that took effect in March 2010 created the "abbreviated licensure pathway" that allows a biosimilar biological product to be licensed based on less than full data.
"Biosimilars will provide access to important therapies for patients who need them," FDA Commissioner Margaret Hamburg
"Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency's rigorous safety, efficacy and quality standards."

The FDA said that for this approval it has given Zarxio a "placeholder" substitute name of filgrastim-sndz, compared with Amgen's Neupogen (filgrastim) for the time being, until it decides how biological products marketed in the US should be named.
Neupogen was originally licensed in 1991. Amgen shares sank 2.4 percent to USD 155.75 in midday trade on the Nasdaq Stock Market.