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 Mylan and Fujifilm Kyowa Kirin Biologics said on Thursday they had
won a European Commission green light to market their version of the
injectable medicine, known as Hulio. They intend to launch it in
Europe on or after Oct. 16, when AbbVie's primary European patent on
Humira expires.
The large number of Humira copies reflects intense rivalry for a
slice of a huge market as demand for so-called biosimilars takes off
in Europe, where adoption of the cut-price products has been much
faster than in the United States.
Europe accounted for around $4.4 billion of Humira's global sales in
the 12 months to June 30, 2018, according healthcare data
consultancy IQVIA.
Amgen, Novartis's generics wing Sandoz, South Korea's Samsung
Bioepis and Germany's Boehringer Ingelheim have already won approval
for four other biosimilars to Humira.
Humira is used to treat a range of conditions including rheumatoid
arthritis, Crohn's disease, ulcerative colitis and psoriasis.
Its commercial success and popularity among patients means it has
become a major cost for health systems across Europe, and health
administrators say they will waste no time in exploiting the arrival
of cheaper biosimilars to drive down bills.
Because injectable biologic drugs such as Humira are made in living
cells, they cannot be exact replicas of the original medicine, so
regulators have come up with the notion of biosimilars - drugs that
are similar enough to do the job.
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The conventional wisdom has been that biosimilar uptake would be
slow and price discounts modest, since these products are expensive
to develop and doctors may be wary about using a medicine that isn't
identical to the original.
But Europe's recent experience with the first wave of biosimilar
antibody drugs - the biggest section of the biologic market - has
upended expectations, suggesting AbbVie will face fierce
competition.
Still, analysts don't expect global Humira sales to fall off a cliff
just yet, since there are delays in the arrival of biosimilars in
the all-important U.S. market.
While expiry of the Humira patent opens the door to biosimilars in
Europe, such copies are not expected to launch in the United States
until 2023.
(For a graphic on 'AbbVie's Humira riding high, for now' click
https://tmsnrt.rs/2P9p7z8)
(Reporting by Ben Hirschler; editing by Jason Neely and David Stamp)
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