Pfizer's
biosimilar of Amgen, J&J's anemia treatments gets FDA
nod
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[May 16, 2018] By
Tamara Mathias and Manas Mishra
(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.
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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
https://investors.pfizer.com/investor-news/press-release-details/2017/Pfizer-Provides-Update-on-Proposed-Epoetin-Alfa-Biosimilar/default.aspx
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.
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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)
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