March 10, 2015 -- Drugs known as biologics have grabbed headlines over the years, both for their potential in fighting cancer and other diseases, and for their high price tag.
Now, the FDA's approval of the first so-called “biosimilar” drug clears the way for manufacturers to make lower-cost versions of those expensive drugs, saving patients money and improving access to the medications.
The company Sandoz got approval last week to market its drug Zarxio as a biosimilar product to Amgen's Neupogen, originally licensed in 1991.
Both drugs help people with cancer whose white blood cell counts have fallen to low levels, which puts them at risk for dangerous infections. But the biosimilar product is expected to cost up to a third less than the original, experts predict.
WebMD turned to experts and the FDA to find out more.
What are biosimilar drugs?
They are similar to, but not an exact copy of, a biologic drug.
Biologic drugs can be made from a variety of natural sources -- human, animal, or microorganisms, the FDA says. They may be made up of sugars, proteins, or things like cells or tissues, according to the agency. Some are made using genetic technology.
Among the commonly used biologics are adalimumab (Humira) for rheumatoid arthritis and trastuzumab (Herceptin) for breast cancer. The most expensive biologics can cost $50,000 a year or more.
It's not as easy to make a biosimilar drug as it is to make a generic version of a brand-name drug. That's because most drugs are made from chemicals and have a known structure. Biologic drugs are more complex.
Biosimilar drugs, while similar to the biologic drug, have “allowable differences because they are made from living organisms,” the FDA says.
The FDA now has the authority to approve biosimilar products under a provision of the Affordable Care Act.
The biosimilar product can be OK'd only if it works the same way as the biologic drug. It must be used in same way, at the same doses and strength, and for the same conditions and indications. The manufacturing sites have to meet FDA standards.
source : Biosimilar Drugs: FAQ
