The U.S. Food and Drug Administration (FDA) on Feb. 6 approved "filgrastim-sndz," the first "biosimilar" or non-brand, complex biopharmaceutical in U.S. pharmaceutical history.

Made by Sandoz, the drug will be sold in the US under the brand name, Zarxio. Biopharmaceuticals can't be considered generic drugs because the former are much larger and more complex protein-based molecules. Generics refer to so-called small molecule drugs that are off-patent.

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The newly approved drug has active ingredients similar to filgrastim or Neupogen, which gained worldwide sales of US$1.2 billion in 2014 for Amgen, an American multinational biopharmaceutical company. The drug is helpful in preventing infections and was provided to cancer patients under treatment.

The FDA said this new drug met the five conditions necessary for sale approval. These are the same conditions Neupogen had to accomplish.

Zarxio will be used to help cancer patients under various treatments avoid infections.

In Europe, biosimilar drugs have been available for patients since 2006. In the United States, however, it wasn't until 2010 when the Affordable Care Act, or Obamacare, came into effect that the FDA gained authority to approve biosimilars.

 "Biosimilars will provide access to important therapies for patients who need them. 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," said FDA Commissioner Margaret Hamburg.

Health insurance agencies consider biotech medicine with expired patents will also be confronted with lower-cost competitors in the U.S. This will lead to some reductions in costs, the same way generic forms of conventional drugs have reduced the cost of prescriptions.

Biological drugs can cost a patient ten of thousands of dollars per year, representing 30 percent of the sum spent by the U.S. on medication.

There is one issue still unsolved when it comes to biotech drugs and that's its official generic name, an important aspect for pharmacists when carrying out prescriptions. The FDA stated that for the time being, the name will be "filgrastim-sndz". It will remain this way until the company establishes a complete naming policy.

Sandoz didn't give any details about the price of the drug but Carol Lynch, Sandoz's global head of biopharmaceuticals and oncology injectables, said the price would be competitive.

TagsZarxio's First Biosimilar Drug, Zarxio, Biosimilar Drug, FDA, Food and Drug Administration, Biotechnology