Swiss drugmaker Novartis’ logo is seen behind scaffolding at the company’s plant in the northern Swiss town of Stein, shown in January. The company’s “biosimilar” drug Zarxio has received FDA approval. Arnd Wiegmann/Reuters/Landov
itoggle caption Arnd Wiegmann/Reuters/Landov
The Food and Drug Administration has approved the first in a class of generic drugs that are made from living cells instead of chemical compounds.
So-called biosimilar drugs “are complex medications made or extracted from living cells, blood components and tissue,” The Wall Street Journal says.
The WSJ adds: “Biosimilars, unlike traditional generics, aren’t precisely identical to the brand drug.
The FDA says that biosimiliars must have no “clinically meaningful differences” in safety or effectiveness and must work in the same way as the drugs they are meant to substitute.
The FDA says today that it has approved the first biosimilar, a drug called Zarxio, made by Novartis AG’s Sandoz unit and meant to boost white blood cells in chemotherapy patients.
As NPR’s Rob Stein reports, the decision is expected to open the door to getting many more, less costly versions of expensive drugs on the market.
Zarxio is a generic version of a drug that costs more than $ 3,000 for a one month regime. The biosimilar version costs about $ 1,000.
Rob notes: “That may not sound like a lot. But the drug’s used a lot. So, according to one estimate, the cheaper, generic version could save the U.S. health care system nearly six billion dollars over the next decade.”