Food & Drug Administration Approves First Biosimilar Drug In U.S.

The Food & Drug Administration has approved the first biosimilar product in the U.S., opening the door for lower cost, generic-like biological drugs to enter the market. The product, called Zarxio (filgrastim-sndz), was developed by Sandoz as a less expensive alternative to Amgen’s Neupogen (filgrastim), a biologic drug prescribed to boost white blood cells in cancer patients.

Biosimilars are not exact duplicates of already approved biologic drugs. Rather, they are products that, when administered to people, behave in a highly similar manner to an already approved biologic drug. Unlike conventional small-molecule drugs, which can be easily copied, biologics are made from living organisms and thus vary from one batch to the next.

Biologic products tend to be the drugs with high price tags, says John Jenkins, director of FDA’s Office of New Drugs. And they are one of the fastest-growing segments of the pharmaceutical market.

Congress gave FDA the authority to approve copycat versions of biologics, or biosimilars, in 2010 under a provision of the Affordable Care Act that aims to boost competition in the biologics marketplace. “One of the goals is to see lower prices to make access better for the patients who need these products,” Jenkins says.

To get biosimilars onto the market quickly, FDA developed a regulatory path that requires companies to submit fewer clinical and preclinical data for biosimilars than for new biologics. Manufacturers must show that there are no clinically meaningful differences between a biosimilar product and an already approved reference product for a particular indication.

For Zarxio, FDA reviewed structural and functional characterization data, animal studies, human pharmacokinetic and pharmacodynamics information, clinical immunogenicity data, and other clinical safety and effectiveness evidence. “We concluded that Zarxio is highly similar and there are no clinically meaningful differences compared to Neupogen,” Jenkins says.

Filgrastim has been proven to have clinical value, “but it is underused in the U.S. for a variety of reasons, including price,” says Louis M. Weiner, director of the Lombardi Comprehensive Cancer Center at Georgetown University. Biosimilars have the potential to increase patients’ access to certain drugs, he says, adding, “The approval of Zarxio may reduce costs to the health care system.”

FDA expects to approve other biosimilars in the near future. The agency has at least four applications under review.