By Jennifer Clopton
WebMD Health News
Reviewed by Michael W. Smith, MD
Sept. 1, 2016 -- The FDA cleared the way for what is hoped may be a more affordable version of the popular arthritis drug Enbrel. Tuesday the agency approved Erelzi (etanercept-szzs), a "biosimilar" to Enbrel.
Latest Arthritis News
The FDA says the two medications work the same way and are both safe and effective. The industry stops short of calling this a generic version of Enbrel, however, because the two drugs have minor differences that keep them from being considered exactly the same.
Enbrel is one of the most widely used biologics on the market. It was approved in 1998 to treat moderate to severe rheumatoid arthritis (RA) and earned more than $5 billion in sales last year. But the high price tag of Enbrel and other biologics make them too expensive for many people -- sometimes $3,000 or more a month.
But patients may have to wait for those cost savings from Erelzi a bit longer. Legal wrangling could delay its release, so it's unclear when it may be available.
Here is some more information about Erelzi:
What is the new drug used to treat?
Erelzi is given by injection. It can be used to treat the same diseases as Enbrel. That includes:
- Moderate to severe RA, either on its own or in combination with the drug methotrexate
- Moderate to severe juvenile arthritis in patients over the age of 2
- Psoriatic arthritis in combination with methotrexate in patients who don't respond to that drug by itself
- Active ankylosing spondylitis
- Moderate to severe plaque psoriasis in patients over the age of 18
How does it work?
Erelzi and Enbrel block the effects of the protein, lowering inflammation and pain. That can stop joint damage and in some cases even reverse it.
What is a biosimilar drug?
Biologic drugs are made from parts of living organisms. They have transformed the treatment of inflammatory diseases and offer an alternative to people who don't respond well to traditional drugs.
The Affordable Care Act allowed for the creation of biosimilars, which are near copies of biologics. The FDA says they have only "minor" differences.
Erelzi is the third biosimilar approved by the FDA. A biosimilar to Humira, which treats many of the same types of inflammatory diseases, received approval from an FDA panel in July. The agency is expected to announce a decision on final approval this month.
How well does Erelzi work?
The FDA reviewed four studies in 216 healthy people comparing Enbrel and Erelzi and a study in 531 people with chronic plaque psoriasis who randomly received one of the two drugs. Those studies showed no differences in the two groups, researchers say.
"A biosimilar is almost identical in structure to the parent drug and there should not be any problem taking it, although long-term safety data is lacking," says Yousaf Ali MD, chief of rheumatology at The Mount Sinai Hospital in New York.
Who shouldn't take it?
People with sepsis (a blood infection) or who have an active infection should not take Erelzi, according to the FDA and the manufacturer, Sandoz Inc. Children should get their vaccines before starting Erelzi, according to Sandoz, as live vaccines taken with the medication could weaken a child's immune system. The same cautions are in place for Enbrel.
What are the side effects?
Common side effects include infections and injection site reactions, according to the FDA. Other side effects include headaches and upper respiratory or sinus infections, according to Sandoz.
More serious side effects, however, have been reported. Those are rare and include tuberculosis and other invasive fungal infections, which can be fatal, according to Sandoz. In addition, lymphoma and other cancers, some fatal, have been reported in children and teens. The side effects are the same seen with Enbrel.
Erelzi will contain a "black box warning" on the increased risk of serious infections like tuberculosis and fungal infections, the FDA says. It also notes that lymphoma and other cancers have been reported.
When will it be available, what will it cost, and will insurance cover it?
In theory, biosimilars should be cheaper than the biologics they are based on. But a spokesperson for Sandoz says Erelzi doesn't have a price yet.
Duncan Cantor, global head of external relations for Sandoz, says it will be "competitively priced." For comparison, a month's supply of Enbrel is about $4,000.
Ali says insurance coverage will affect how often doctors prescribe the drug. He says he would only switch from Enbrel if the cost of that drug was prohibitive. "It would be inappropriate to switch patients who are stable on Enbrel to Erelzi purely due to cost saving since there would be a theoretical risk of disease worsening or lack of response," he says.
There's no release date yet for Erelzi. Amgen Inc., the maker of Enbrel, filed lawsuit against Sandoz to stop it from selling Erelzi, says Amgen spokesperson Kristen Davis. The company says the drug violates its patent for Enbrel.
A court trial is scheduled for April 2018.
SOURCES: Yousaf Ali MD, chief of rheumatology, The Mount Sinai Hospital in New York. Duncan Cantor, Sandoz global head of external relations. Kristen Davis, Amgen spokesperson. Enbrel.com: "What is Enbrel," "How Enbrel works." Novartis: "FDA approves Sandoz Erelzi(TM) to treat multiple inflammatory diseases." FDA: "What Are "Biologics" Questions and Answers," "Information on Biosimilars," "FDA approves Erelzi, a biosimilar to Enbrel." FDA, Sandoz Briefing Information for July 13, 2016 Meeting of the Arthritis Advisory Committee.
©2016 WebMD, LLC. All Rights Reserved.