FDA
panel backs Amgen copy of AbbVie arthritis drug Humira
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[July 13, 2016]
By Toni Clarke
(Reuters) - Amgen Inc's cheaper version of
AbbVie's top-selling arthritis drug Humira is highly similar to the
original and should be approved, an advisory panel to the U.S. Food and
Drug Administration concluded on Tuesday.
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The panel voted 26-0 that the drug, ABP 501, which was studied in
rheumatoid arthritis and plaque psoriasis, was similar in safety and
effectiveness to the original.
AbbVie is trying to block Amgen's drug from reaching the market. It
claims it has patents in place to protect Humira, the world's
biggest-selling drug, in the United States until at least 2022.
The panel concluded that the study results could be extrapolated to
other conditions for which Humira is approved, including adult
Crohn's disease and ulcerative colitis and should be approved for
those conditions as well.
The FDA is not obliged to follow the advice of its advisory
committee but typically does so. The panel's conclusions were
consistent with those of FDA scientists, who published their
preliminary review of the drug on Friday.
Panelists had some reservations about approving the drug for
indications for which it had not been tested in clinical trials and
urged the FDA to require companies to conduct post-market
surveillance studies to make sure the product works as expected in
those conditions.
"I voted yes despite reservations about extrapolating from the data
we have, which was good, to the data we don't have and will never
have," said Nancy Geller, a biostatistician at the National
Institutes of Health.
Panelists also urged greater education of the public about
biosimilars, copies of biologic drugs made from living cells.
Biosimilars are more complex than traditional pills and cannot be
copied with precision. Biosimilars are not interchangeable with the
original product.
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Amgen could introduce its drug before the patent dispute with AbbVie
is resolved, but risks facing triple damages from an unfavorable
court ruling. Some analysts expect the drug to be available well
before 2022 and expect sales of Humira to fall as much as 18 percent
in 2019.
Humira last year generated U.S. sales of more than $8 billion.
On Wednesday the panel will vote on whether the FDA should approve
Novartis AG's cheaper version of Amgen's arthritis drug Enbrel.
Enbrel and Humira both belong to a class of drugs that block a
protein involved in inflammation known as tumor necrosis factor, or
TNF.
(Reporting by Toni Clarke in Washington; editing by G Crosse, Leslie
Adler and David Gregorio)
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