FDA News

FDA approves Retacrit, an Epogen/Procrit biosimilar, for treatment of anemia

The FDA today approved epoetin alfa-epbx, the first epoetin alfa biosimilar, for the treatment of anemia caused by chemotherapy, chronic kidney disease or the use of zidovudine in patients with HIV infection.

Epoetin alfa-epbx (Retacrit, Hospira/Pfizer) — a biosimilar to epoetin alfa (Epogen/Procrit, Amgen) — also is indicated for use before and after surgery to reduce the chance that red blood cell transfusions will be needed due to blood loss during surgery.

The FDA based the biosimilar’s approval on data from structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data showing epoetin alfa-epbx is biosimilar to epoetin alfa.

“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 press release. “Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.”

The most common side effects of epoetin alfa-epbx-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.

The prescribing information includes warnings about risks for death; heart problems; stroke; tumor growth or recurrence; high blood pressure; seizures; a condition in which the bone marrow stops making red blood cells, thus, causing anemia; serious allergic reactions and severe skin reactions.

The FDA today approved epoetin alfa-epbx, the first epoetin alfa biosimilar, for the treatment of anemia caused by chemotherapy, chronic kidney disease or the use of zidovudine in patients with HIV infection.

Epoetin alfa-epbx (Retacrit, Hospira/Pfizer) — a biosimilar to epoetin alfa (Epogen/Procrit, Amgen) — also is indicated for use before and after surgery to reduce the chance that red blood cell transfusions will be needed due to blood loss during surgery.

The FDA based the biosimilar’s approval on data from structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data showing epoetin alfa-epbx is biosimilar to epoetin alfa.

“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 press release. “Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.”

The most common side effects of epoetin alfa-epbx-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.

The prescribing information includes warnings about risks for death; heart problems; stroke; tumor growth or recurrence; high blood pressure; seizures; a condition in which the bone marrow stops making red blood cells, thus, causing anemia; serious allergic reactions and severe skin reactions.

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