FDA approves Pfizer’s epoetin alfa biosimilar Retacrit
The Food and Drug Administration on Tuesday approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa).
The biosimilar, from Pfizer’s Hospira was approved for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit 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,” stated Leah Christl, director of the Therapeutic Biologics and Biosimilars Staff in the FDA’s Center for Drug Evaluation and Research. “Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.”
Pfizer said that it would be working with Vifor Pharma on commercialization in certain channels for Retacrit — the company’s third approved biosimilar in the United States. The lower-cost alternatives to branded biologic drugs — which are not interchangeable products — are set to play a big role in the Trump Administration’s plan to lower drug prices.
“As the first approved epoetin alfa biosimilar in the United States, Retacrit may provide patients and their physicians with increased access to a high-quality, lower-cost alternative treatment option for anemia and the reduction of allogeneic red blood cell transfusions in certain patients,” said Berk Gurdogan, U.S. institutions president at Pfizer Essential Health. “We are proud of the progress of our biosimilars program to date, which will help address the evolving needs of patients and the broader healthcare community.”
The biosimilar, from Pfizer’s Hospira was approved for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit 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,” stated Leah Christl, director of the Therapeutic Biologics and Biosimilars Staff in the FDA’s Center for Drug Evaluation and Research. “Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.”
Pfizer said that it would be working with Vifor Pharma on commercialization in certain channels for Retacrit — the company’s third approved biosimilar in the United States. The lower-cost alternatives to branded biologic drugs — which are not interchangeable products — are set to play a big role in the Trump Administration’s plan to lower drug prices.
“As the first approved epoetin alfa biosimilar in the United States, Retacrit may provide patients and their physicians with increased access to a high-quality, lower-cost alternative treatment option for anemia and the reduction of allogeneic red blood cell transfusions in certain patients,” said Berk Gurdogan, U.S. institutions president at Pfizer Essential Health. “We are proud of the progress of our biosimilars program to date, which will help address the evolving needs of patients and the broader healthcare community.”