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Novartis’ white blood cell-boosting Zarxio the first biosimilar drug has been approved by the FDA (The Food and Drug Administration). On Friday, March 6, U.S. regulators approved the sale of the first ever biotechnology drug.
Zarxio contains the same active compound as Neupogen, developed by Amgen Inc. which in 2014 brought the company a profit of $1.2 billion from its sales. This new drug was developed by Novartis’ Sandoz generic unit.
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.
Health insurance agencies consider that 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 even tens of thousands of dollars per year, representing 30 percent of the sum spent by the U.S. on medication.
In comparison to chemical compounds like aspirin or statins, biotech medicine is generated within living cells so small variations do occur, depending on the production method. This means, “a copycat version can only ever be similar to the original, rather than identical”.
There is one issue still unsolved when it comes to biotech drugs and that is 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.
It is expected that the wholesale price for the smallest packaged daily dose will be $315 but Sandoz did not give any information regarding Zarxio’s official price. Carol Lynch, global head of biopharmaceuticals and oncology injectables said that it will be “competitively priced”.
The competitor, Amgen will file a lawsuit in an attempt to block the release of Zarxio. Sandoz had initially agreed to postpone the launch until the court decides whether Amgen’s request will be accepted or not but is now planning on releasing the drug until April 10.
Image Source: Cancer Therapy Advisor
