(Reuters) – Pfizer Inc’s biosimilar of anemia treatments from Amgen Inc and Johnson & Johnson was approved by U.S. health regulators on Tuesday setting it up to compete against the established brands.
The approval comes one year after the U.S. Food and Drug Administration rejected the drug, Retacrit, a copy of Amgen’s Epogen and Johnson & Johnson’s Procrit, as a treatment for a drop in red blood cells caused by chronic kidney disease, chemotherapy, or the use of zidovudine in patients with HIV.
The biosimilar was also approved for use before and after surgery to safeguard against the need for red blood cell transfusions due to blood loss from surgery.
Amgen earned a revenue of $ 1.10 billion from Epogen in 2017, which accounted for about 5 percent of the company’s total sales.
Johnson & Johnson’s Procrit brought in sales of $ 972 million in 2017, accounting for 2.7 percent of its total sales.
Last year, an independent panel of advisors to the U.S. regulator recommended Retacrit’s approval, but the agency rejected the drug citing here issues with a potential manufacturing site in Kansas.
Shares of Johnson & Johnson dipped 1.3 percent and Amgen’s shares fell 2.5 percent in afternoon trading. Pfizer’s shares were down marginally.
Reporting by Tamara Mathias in Bengaluru; Editing by Shailesh Kuber