By Kathleen Doheny
WebMD Health News
Reviewed by Arefa Cassoobhoy, MD, MPH
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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.
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.
To gain FDA approval for its cancer drug, drug-maker Sandoz submitted data to the agency, including a study that compared it to the original biologic drug.
Why is this new class of drugs important?
"We think and hope it will reduce the costs of these medications," says Michael Cohen, RPh, president of the Institute for Safe Medication Practices. That's partly possible, he says, due to lower research costs.
The cost drop is expected to be more modest than for generic versions of brand-name drugs, says Gary Lyman, MD, MPH, co-director of the Hutchinson Institute for Cancer Outcomes Research in Seattle.
In general, he says, generics cut the cost of brand-name drugs by 60% to 80%. For the biosimilar products, ''the projections are perhaps a 20% to 30% reduction" over the cost of the original biologics, Lyman says.
How else could biosimilar drugs help people?
The competition is expected not only to drive down prices, but to increase access to drugs for patients, says Scott Soefje, PharmD, MBA, director of pharmacy at the University Medical Center Brackenridge in Austin.
Will the biosimilar products work as well as the biologics?
Makers of the biosimilar products must show that there are no meaningful differences in terms of safety and effectiveness from the original products. While the biosimilar drugs are not supposed to have any different side effects than the original ones, Cohen says that might not always bear out.
"From a scientific perspective, the concerns are that the biosimilar molecule is not exactly the same and that it has either not as good an effect or a side effect we didn't anticipate," Soefje says.
To track the results and side effects, it would be easier if the biologics and biosimilar drugs had non-brand names that stood out, Soefje and Cohen agree. When the FDA approved Zarxio, it gave it the non-brand name filgrastim-sndz to show it is Sandoz's version. But the FDA is still deciding how biosimilar products should be named on a permanent basis.
What should you do if a health care provider offers you a biosimilar drug?
Ask your doctor, nurse, or pharmacist to "explain exactly what the clinical trial showed, and be comfortable that using these drugs is going to produce the same results. If they are convinced it is going to produce the same results, biosimilar may be the way to go, because it is cheaper," Soefje says.
An approved biosimilar may be substituted for the original, the FDA says, without a doctor prescribing the biologic.
What about insurance coverage?
"If an insurance plan covers the biological, they would be expected to also cover the biosimilar," Cohen says.
Lyman reports receiving research funds to the Fred Hutchinson Cancer Center from Amgen to study neutropenia, the condition treated by Neupogen. Soefje reports consulting work for Amgen on a new drug.
SOURCES: Press release, Novartis. Michael Cohen, RPh, president, Institute for Safe Medication Practices, Horsham, PA. Gary Lyman, MD, MPH, oncologist and health economist; professor of medicine, University of Washington; co-director, Hutchinson Institute for Cancer Outcomes Research at Fred Hutchinson Cancer Research Center, Seattle. Scott Soefje, PharmD, MBA, director of pharmacy, University Medical Center Brackenridge, Austin, Texas; incoming president, Hematology/Oncology Pharmacy Association. FDA: "Biosimilars." FDA: "What Are 'Biologics': Questions and Answers."
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