he precipitous patent cliff of
2012 assaulted Big Pharma
to the tune of up to $53 billion worth of prescription
drug sales potentially lost
to patent expirations. 2015 represents the
next highest total since then, with a projected figure of $44 billion in sales that
could be lost due to expired patents. This
time, however, the brunt is expected to be
much less widespread than the 2012 impact as more than sixty percent of the sales
are tied to biotechnology drugs that are
not yet facing biosimilar competition in
the United States and in some other major
markets despite losing exclusivity in 2015.
As a result, generics have been forecasted
to erode $16 billion in prescription-drug
sales this year.
With most blockbuster biotech brands
expected to continue to thrive in the near
term minus significant biosimilar competition, the pharma/biotech industry is
experiencing a substantial growth period.
Global prescription drug sales have been
projected by various industry analysts to
continue growing, at nearly a five per-
cent rate annually until 2020. Aiding the
growth rate is a new wave of first-in-class
blockbuster products and a recent in-
crease in research and development pro-
ductivity. A total of 41 new molecular enti-
ty and new therapeutic biological products
were approved by the U.S. Food and Drug
Administration during 2014, the second-
highest total ever (there were 53 new drug
approvals by FDA in 1996). Also contrib-
uting to the yearly Rx drug growth is a
massive sales eruption from new hepatitis
C treatments that began in fourth-quarter
2013 and continues to surge during 2015.
Humira leads the pack
For the third consecutive year, Humira
was the top-selling prescription medicine.
During 2014, the biologic therapy generated global sales of about $12.86 billion
between marketers AbbVie Inc. and
Eisai Co. Administered as a subcutaneous injection, Humira (adalimumab) is
approved for a variety of autoimmune diseases. The medicine stems from the anti-tumor necrosis factor alpha monoclonal
antibody drug class.
Launched in the United States during January 2003, Humira is available in
more than 87 countries including Japan,
China, Brazil, and Australia. The product
is used for treating over 850,000 patients
across 13 globally approved indications.
In North America and the European
Union, the drug is marketed for rheuma-
toid arthritis (moderate to severe), pso-
riatic arthritis, ankylosing spondylitis,
Crohn’s disease, plaque psoriasis (mod-
erate to severe), and juvenile idiopathic
arthritis. In the United States, Humira is
available for ulcerative colitis (moderate
to severe), axial spondyloarthropathy, and
pediatric Crohn’s disease (severe). Humira
is also approved in the EU for pediatric
enthesitis-related arthritis. According to
AbbVie’s second-quarter 2015 report, the
company recently received clearance from
the EMA for a new Humira formulation
specifically designed to reduce injection
pain and reduce injection volume.
Also during first-half 2015, AbbVie announced results from VISUAL-I, a Phase
III trial investigating the efficacy and safety of Humira in adult patients with uveitis.
Results demonstrated that the drug significantly lowered patients’ risk of uncontrolled uveitis or vision loss. AbbVie has
gained orphan drug designation from U.S.
regulators for the investigational treatment of certain forms of non-infectious
uveitis with Humira. U.S. and EU regulatory filings are expected during second-half 2015, following positive results from
the second pivotal study.
For first-half 2015, AbbVie reported
Humira global sales of $6.65 billion. January-June 2015 international sales rose
almost 9 percent on an operational basis.
Strong U.S. growth for Humira continued
throughout second-quarter 2015, spurred
by double-digit growth across all three
major market categories: rheumatology,
dermatology and gastroenterology.
The U.S. composition of matter patent covering adalimumab is scheduled
to expire during December 2016. The
equivalent EU patent is slated to run its
course in the majority of those countries
by April 2018.
The Magazine of Pharmaceutical Business and Marketing • medadnews.com • August 2015 • Volume 34, Number 4 • $25
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Humira during 2014 remained the world’s
best-selling prescription medicine.
place in its ;rst
full year on
the 2015 sales