A federal agency has approved a similar version of a highly complex drug, introducing a new class of cheaper versions of life-saving drugs to the United States.
The U.S. Food and Drug Administration on Friday approved a biosimilar from Sandoz that closely resembles an Amgen drug called Neupogen, which replenishes white blood cells in cancer patients.
A biosimilar is, as the name implies, a drug that is very similar to a product already on the market. Biosimilars have to be safe and effective like the product on the shelves, but can have minor changes, according to the agency. They are different than a generic drug, which must be an exact copy of a drug already on the market.
A biosimilar can have slight changes because they resemble biologic products, which are very complex and difficult to make, the agency said. A biologic is made from living organisms such as proteins or cells, which differ from regular drugs made from chemicals. An example of a biologic is a vaccine.
Because biologics are very expensive to make, they are expensive to buy. For example, a drug called Soliris that treats a rare blood disease costs $400,000 a year per patient, according to a report from the think tank American Consumer Institute Center for Citizen Research.
Another popular biologic called Humira is used to treat rheumatoid arthritis and costs about $50,000 a year, according to a 2012 study.
Biosimiliars are intended to provide such drugs at a lower cost. Europe already has several biosimilars on the market that are as much as 50 percent cheaper than the reference biologic, the researchers said.
A study from the think tank RAND Corporation estimates that biosimilars will lead to a $44.2 billion reduction on spending for biologic drugs over the next decade.
Sandoz couldn’t say how much the Neupogen biosimilar will cost, but did tell the Washington Examiner that it will be “competitively priced.”
The Affordable Care Act created a pathway for the agency to approve biosimilars, but none had been approved until now.
