First Biosimilar for Anemia Treatment Approved by FDA

Epoetin alfa-epbx, a biosimilar to epoetin alfa, was approved for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. The biosimilar, like its reference product, also is indicated for use before and after surgery to reduce the need for red blood–cell transfusions due to blood loss.

The U.S. Food and Drug Administration voted to approve epoetin alfa-epbx after a review of its 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 AEs associated with epoetin alfa-epbx and its reference product 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 risk 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.

Source: FDA news release, May 15, 2018.