WASHINGTON, May 15 (Xinhua) -- The U.S. Food and Drug Administration (FDA) approved on Tuesday a biosimilar to epoetin alfa (Epogen or Procrit) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection.
The new medicine Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery, according to FDA.
"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," said Leah Christl, director of the Therapeutic Biologics and Biosimilars Staff in the FDA's Center for Drug Evaluation and Research.
"Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs."
Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast.
A biosimilar is a biological product that is approved based on data showing that it is highly similar to a biological product already approved and has no clinically meaningful differences in terms of safety, purity and potency from the reference product, in addition to meeting other criteria specified by law.
