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 The FDA approved the drug, Erelzi, known also as etanercept-szzs,
for multiple inflammatory conditions including rheumatoid arthritis
and plaque psoriasis, a skin condition.
The agency approved the drug as a biosimilar, meaning there are no
clinically meaningful differences between Erelzi and Enbrel. But the
two drugs are not considered interchangeable and are therefore not
called generics.
Enbrel is a biologic drug made from living cells. Biologics are more
difficult to imitate.
The FDA's ruling followed a unanimous vote by the agency's advisory
panel in July in favor of approval.
"We are committed to bringing Erelzi to the U.S. market as soon as
possible," said Carol Lynch, global head of biopharmaceuticals at
Novartis' Sandoz unit in Germany.
Enbrel was approved in 1998 and generated more than $5 billion in
U.S. sales last year. It works by blocking a protein known as tumor
necrosis factor, or TNF, that plays a role in inflammatory
conditions.
Amgen believes Enbrel has U.S. patent protection until 2029 and is
fighting in court to keep Novartis' drug off the market.
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The FDA is also weighing approval of Amgen's biosimilar version of
AbbVie's arthritis drug Humira, a TNF inhibitor that last year
generated U.S. sales of more than $8 billion.
AbbVie is in turn trying to block Amgen's drug from reaching the
market, saying it has patents in place to protect Humira in the
United States until at least 2022.
(Reporting by Toni Clarke in Washington; Additional reporting by
John Miller in Zurich and Bill Berkrot in New York; Editing by Alan
Crosby and Peter Cooney)
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