The U.S. Food and Drug Administration (FDA) approved epoetin alfa-epbx as a biosimilar to epoetin alfa for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. The agent also is indicated for use before and after surgery to reduce the need for red blood cell transfusions due to blood loss.
The approval of this biosimilar product is based on a review of epoetin alfa-epbx’s structural and functional characteristics, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data – all of which demonstrate that the product is biosimilar to its reference product. In its approval notice, the FDA stressed that epoetin alfa-epbx is approved as a biosimilar and not as an interchangeable product.
The decision was supported by data from two single-center, randomized, open-label studies (EPOE-12-02 and EPOE-14-01) that established the pharmacodynamic and pharmacokinetic data of epoetin alfa-epbx 100 u/kg as a single dose or multiple doses in healthy participants. In each trial, the biosimilar met prespecified acceptance criteria for similarity with its reference product.
The most common adverse events associated with epoetin alfa and epoetin alfa-epbx include hypertension, joint pain, muscle spasm, fever, dizziness, medical device malfunction, and blood vessel blockage. As with epoetin alfa, the biosimilar carries a boxed warning about increased risks of death, heart problems, stroke, and tumor growth or recurrence. Additional warnings include high blood pressure, seizures, aplastic anemia, serious allergic reactions, and severe skin reactions.
“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,” Leah Christl, PhD, director of the Therapeutic Biologics and Biosimilars Staff in the FDA’s Center for Drug Evaluation and Research, said in a statement from the agency. “Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs,” she added.
Source: FDA news release, May 15, 2018.