(Reuters) – Pfizer Inc’s Retacrit was approved by U.S. health regulators as a biosimilar to current anemia treatments from Amgen Inc and Johnson & Johnson on Tuesday, setting it up to compete against more established brands.
A year ago the U.S. Food and Drug Administration rejected Retacrit as a copy of Amgen’s Epogen and Johnson & Johnson’s Procrit, citing here issues with a potential manufacturing facility in Kansas.
Shares of the rival companies dipped in afternoon trade.
“People were surprised last time when Pfizer didn’t get a first round approval for a biosimilar, so I think people certainly expected it this time. Its not a surprise,” Baird analyst Brian Skorney said.
Epogen’s $ 1.10 billion in sales accounted for about 5 percent of Amgen’s 2017 revenue, but analysts believe a competing product is unlikely to hurt the company.
“Its nice to see that the FDA is moving along and approving biosimilars but the commercial impact to Amgen is quite minimal,” Jefferies analyst Michael Yee, who has a “buy” rating on Amgen’s stock, told Reuters.
Johnson & Johnson’s Procrit brought in sales of $ 972 million in 2017, accounting for 2.7 percent of its total sales.
The FDA has been pushing to approve copies of expensive branded drugs to increase competition in the market as the Trump administration rallies against exorbitantly priced medicines.
Biosimilars aim to copy biologic products, which are made inside living cells, but they can never be exact duplicates.
Tuesday’s approval allows Retacrit’s use as a treatment for a drop in red blood cells caused by chronic kidney disease, chemotherapy, or the use of zidovudine in HIV patients.
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.
Shares of Johnson & Johnson dipped 1.2 percent and Amgen’s shares fell 2.5 percent in afternoon trading. Pfizer’s shares were down about 1 pct.
Reporting by Tamara Mathias and Manas Mishra in Bengaluru; Editing by Shailesh Kuber