May 15 (UPI) -- The Food and Drug Administration on Tuesday approved Retacrit as a biosimilar to treat anemia that has been caused by chronic kidney disease or chemotherapy.
The FDA granted approval for the drug as a biosmiliar to Amgen's Epogen and Janssen Biotech's Procrit, which also treats anemia caused by zidovudine to treat HIV infection. The European Medicines Agency approved the biosimiliar of the compound epoetin alfa last year.
Biosimilar products, which are generally derived from living organisms, are approved based on data showing they are highly similar to biological products already approved by the FDA. They have no clinically meaningful difference in safety, purity and potency. The FDA noted Retacrit, which is manufactured by Pfizer, was not approved as an interchangeable product.
In a release, Pfizer said the drug is expected to be available in the United Stated "at a significant discount" to Epogen and Procrit.
The FDA noted the importance of low-priced alternatives.
"It is important for patients to have access to safe, effective and affordable biological products and we are committed to facilitating the development and approval of biosimilar and interchangeable products," Dr. Leah Christl, director of the therapeutic biologics and biosimilars staff in the FDA's Center for Drug Evaluation and Research, said in a press release. "Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs."
Like Epogen and Procrit, Retacrit comes with a warning about increased risks of death, heart problems, stroke and tumor growth or recurrence. Other side effects the manufacturer warns about include high blood pressure, seizures, bone marrow stopping making red blood cells, serious allergic reactions and severe skin reactions.
For patients receiving chemotherapy, Retacrit must be injected under the skin, and for patients about to undergo surgery it must be injected into a vein.
In April, the FDA said it needed "additional technical information," before approving Pfizer's proposed trastuzumab biosimilar of Herceptin, a chemotherapy that treats breast, stomach and esophageal cancer.
Pfizer's lone biosimilar on the U.S. market is Inflectra, which the FDA approved in 2016 to treat Crohn's disease, rheumatoid arthritis, irritable bowel syndrome and other chronic conditions . Pfizer currently has six biosimilars in phase 3 trials.