The approval is backed by evidence from extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data.
The US Food and Drug Administration (FDA) approved epoetin alfa-epbx (Retacrit) as a biosimilar to epoetin alfa (Epogen/Procrit) for the treatment of anemia caused by chronic kidney disease, chemotherapy or use of zidovudine in patients with HIV, announced Hospira Inc.
Additionally, 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.
“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, Therapeutic Biologics and Biosimilar Staff, Center for Drug Evaluation and Research, FDA, said in a statement. “Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.”
The approval demonstrating Retacrit is biosimilar to Epogen/Procrit is based on a review of evidence which included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data.
In clinical studies of the reference product, common side effects of epoetin alfa-treated patients included high blood pressure, joint pain, muscle spasm, fever, dizziness, medical device malfunction, blood vessel blockage, respiratory infection, cough, rash, injection site irritation, nausea, vomiting, muscle pain, inflammation of the mouth and lips, weight decrease, reduction in white blood cells, bone pain, high blood sugar, insomnia, headache, depression, difficulty swallowing, low blood potassium, blood clots, itching, headache, injection site pain and chills.
Retacrit, approved as a biosimilar, is not approved as an interchangeable product.
Similarly, to Epogen/Procrit, Retacrit must be provided with a medication guide providing information about the drug’s uses and risks, and will contain a Boxed Warning to alert health care professionals and patients about increased risks of death, heart problems, stroke and tumor growth or recurrence. Additional warnings include high blood pressure, seizures, a condition in which bone marrow stops producing red blood cells, serious allergic reactions and severe skin reactions.