F.D.A. Approves Zarxio, Its First Biosimilar Drug

The Food and Drug Administration has approved the first so-called biosimilar drug for use in the United States, paving the way for less expensive alternatives to an entire class of complex and costly drugs.

The drug, called Zarxio, produced by Sandoz, is used to help prevent infections in cancer patients receiving chemotherapy. It is a close copy of an existing medication called Neupogen, made by Amgen. It was approved in Europe in 2009 as Zarzio but has not been used in the United States, in part because no regulatory pathway existed to bring biosimilars — approximate copies of drugs in a class known as biologics — to market.

But in January an expert panel unanimously recommended that the F.D.A.approve it, and the agency on Friday announced that it had taken the panel’s advice. ...

The approval is significant because it opens the door to a new class of potentially cheaper lifesaving drugs for millions of Americans. It involves biologic drugs, which are made using living cells and not synthesized from chemicals like typical drugs. Some popular biologic drugs are Remicadeand Enbrel for autoimmune diseases, and Herceptin and Avastin forcancer. Some of the world’s most expensive medications are biologics.

Most brand-name drugs eventually lose their patent protection, opening the market to lower-priced generic products. But until now, biologics have been largely insulated from the competition of cheaper copies.

“This is the first approval for low-cost alternatives to biological drugs,” Ronny Gal, a senior research analyst who focuses on specialtypharmaceuticals at Sanford C. Bernstein & Company, said in an email. “It will reasonably allow for reduction of cost in older cancer care drugs, clearing room in the budgets for new breakthrough cancer agents.”

Biologic drugs were first developed in the 1980s and were considered so specialized that making generic versions was seen as most likely impossible. But science has advanced, and as patents began to expire, drug companies started developing close copies and seeking F.D.A. approval for them. Companies with the original patents initially resisted, arguing that their drugs were so complex that it was not possible to make a copy, but that position eventually became untenable.

more