Amgen Biosimilar Gets Thumbs-Up From FDA Panel
July 12 2016 - 7:20PM
Dow Jones News
The second-biggest selling drug in the world could get some
cheaper competition in the U.S., after a federal panel endorsed an
alternative version of the pricey medication used to treat
rheumatoid arthritis and other inflammatory diseases.
A panel of Food and Drug Administration advisers voted
unanimously in favor of Amgen Inc.'s version of AbbVie Inc.'s
Humira, a biotech drug that, according to IMS Health, raked in
nearly $15 billion last year. While not binding, the recommendation
likely paves the way for FDA approval of the knockoff drug.
For years, biotech drugs faced no competition because there was
no regulatory way to approve copycat versions, even after patents
had expired. If approved, Amgen's drug would join a new wave of
so-called biosimilars, which have the potential to generate
billions in savings for U.S. insurers, doctors and patients.
But it could take years for those savings to arrive.
Evercore ISI analyst Mark Schoenebaum said the earliest Amgen
could launch its product would be March 2017, though that would
risk infringing patents which AbbVie says protect its drug until at
least 2022. Wall Street analysts expect the patent issue to be
fought in court, and then for Amgen's drug to launch some time
between 2018 and 2022.
First approved in 2002, Humira has long been among the most
profitable drugs in the world. It accounted for 60% of AbbVie's
total revenue last year. The injectable drug, which blocks
chemicals linked to inflammation, is approved for multiple uses,
including rheumatoid arthritis, Crohn's disease and psoriasis.
Thousand Oaks, Calif.-based Amgen is seeking FDA approval to
market its version, known only as ABP 501, for seven diseases.
Amgen is itself a biotech powerhouse, and it too has medications
facing competition from cheaper versions. The company is working to
hedge those loses by developing lower-cost versions of competitors'
drugs.
Biotech drugs are powerful, injected medicines produced in
living cells that are typically much more expensive than
traditional, chemical-based drugs. In 2015, six of the 10
top-selling medicines globally were biotech drugs, with more than
$56 billion in combined sales.
The FDA only approved the first lower-cost biotech drug last
year, a Novartis AG version of the Amgen drug Neupogen. Pfizer Inc.
won approval to market a second biosimilar in April, a version of
Johnson & Johnson's Remicade, but it isn't for sale yet.
Questions remain about just how much savings U.S. biosimilars
will deliver. Novartis's Zarxio sells for 15% less than the
original Neupogen. Experts predict biosimilar discounts of 15% to
30% in the U.S.
In Europe, where governments regulate prices, discounts are
higher.
Development of lower-cost anti-inflammatory drugs like Humira is
considered pivotal in reducing U.S. spending on specialty drugs,
which has doubled to $150 billion since 2010, according to IMS
Health.
On Wednesday, the same panel of FDA advisers will review a
Novartis version of Enbrel, which is marketed by Amgen.
Copyright 2016 Associated Press
(END) Dow Jones Newswires
July 12, 2016 19:05 ET (23:05 GMT)
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