Dr. Lyman on the Epoetin Alfa Biosimilar

Gary H. Lyman, MD, MPH
Published: Friday, Mar 29, 2019



Gary H. Lyman, MD, MPH, medical oncologist, Fred Hutchinson Cancer Research Center, discusses the epoetin alfa biosimilar.

The epoetin alfa biosimilar, epoetin alfa-epbx (Retacrit) was approved by the FDA in May 2018 for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. The approval was based predominantly on preclinical work and pharmacokinetic and pharmacodynamic data in healthy volunteers, says Lyman. However, 2 large phase III trials were also conducted in patients with chronic kidney disease. In the United States, the data specific to cancer patients remains observational, says Lyman.

However, the biosimilar, also approved in Europe and known as epoetin zeta, has shown noninferiority to its biologic counterpart, epoetin alfa, in several randomized phase III trials specific to cancer patients. The FDA extrapolated these data and added them to existing safety and efficacy data in patients with advanced kidney cancer to support its use in patients with chemotherapy-induced anemia, adds Lyman. Having a competitive biosimilar with the potential to lower the price of its biologic will hopefully aid patients and providers alike, he concludes.
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Gary H. Lyman, MD, MPH, medical oncologist, Fred Hutchinson Cancer Research Center, discusses the epoetin alfa biosimilar.

The epoetin alfa biosimilar, epoetin alfa-epbx (Retacrit) was approved by the FDA in May 2018 for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. The approval was based predominantly on preclinical work and pharmacokinetic and pharmacodynamic data in healthy volunteers, says Lyman. However, 2 large phase III trials were also conducted in patients with chronic kidney disease. In the United States, the data specific to cancer patients remains observational, says Lyman.

However, the biosimilar, also approved in Europe and known as epoetin zeta, has shown noninferiority to its biologic counterpart, epoetin alfa, in several randomized phase III trials specific to cancer patients. The FDA extrapolated these data and added them to existing safety and efficacy data in patients with advanced kidney cancer to support its use in patients with chemotherapy-induced anemia, adds Lyman. Having a competitive biosimilar with the potential to lower the price of its biologic will hopefully aid patients and providers alike, he concludes.

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