'BioSimilar' Drug Retacrit (Epoetin Alfa-epbx) Approved to Treat Certain Types of Anemia
A biosimilar, derived from a living organism, has been proven to be "highly similar" to a product that's already been approved by the FDA. It's also been shown to have no "clinically meaningful differences" in its safety, purity and potency than the prior approved drugs, the agency explained Tuesday in a news release.
"Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs," said Leah Christi, Ph.D., director of the agency's Therapeutic Biologics and Biosimilars Staff.
Epogen/Procrit are approved to treat anemia caused by chronic kidney disease, chemotherapy or use of certain drugs to treat infection with HIV, the virus that causes AIDS.
Previously noted side effects of epoetin alfa include: high blood pressure, joint pain, muscle spasm, fever, dizziness, blood vessel blockage and respiratory infection, the FDA said.
As with Epogen/Procrit, Retacrit's label includes a boxed warning about increased risk of death, heart problems, stroke, tumor growth, high blood pressure, seizures and serious allergic reactions.
Retactrit is produced by Hospira Inc., a unit of New York City-based Pfizer.
© 2020 HealthDay. All rights reserved.
Posted: May 2018
Read this next
WEDNESDAY, Nov. 13, 2019 -- Reblozyl (luspatercept-aamt) has been approved to treat anemia in adults with beta thalassemia who require regular red blood cell (RBC) transfusions,...
FRIDAY, Sept. 20, 2019 -- Women who suffer from anemia early in pregnancy are at risk for having a child with autism, attention-deficit/hyperactivity disorder (ADHD) and...
WEDNESDAY, July 31, 2019 -- Even mild anemia -- low levels of hemoglobin in the blood -- may raise a person's odds for Alzheimer's disease and other types of dementia, a new study...
More News Resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
- Monthly Update Archive
Subscribe to our Newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.