he world’s top seller
Humira remained No. 1 during
2016 by a huge margin. The
sales-dollar gap between
Humira and second-place
Harvoni amounted to more than $7.4
billion, a total exceeding the sales for every
prescription drug outside of the world’s top
5 products. As the world’s first fully human
anti-TNF-α monoclonal antibody, Humira is approved around the globe to treat a
variety of autoimmune diseases. Containing the active chemical adalimumab. Humira exerts effects by neutralizing TNF-α
(tumor neurosis factor-α), a protein that
plays a central role in inflammatory responses in rheumatoid arthritis and other
immune-mediated inflammatory diseases.
Humira accounted for 63 percent of
AbbVie’s total net revenue during 2016.
The medicine’s sales continued to grow
during the first six months of 2017, reaching $8.83 billion, representing an increase
of 14. 3 percent on a reported basis compared to the drug’s performance in first-half 2016. Humira sales are also recorded by Eisai, which jointly developed and
co-promotes Humira in Japan.
AbbVie continues to dedicate substantial R&D efforts to expanding indications
for the biologic therapy, including in the
fields of rheumatology, gastroenterology
(pediatric ulcerative colitis), and dermatology (pediatric psoriasis). AbbVie also continues to work on Humira formulation and
delivery enhancements to improve convenience and overall patient experience.
According to EvaluatePharma’s “World
Preview 2017, Outlook to 2022” report,
Humira is still expected to be the top-selling medicine in 2022 at $15.9 billion with
a 28. 7 percent global market share.
After generating $13.86 billion in 2015
worldwide sales, Harvoni stayed in second
place during the 2016 calendar year despite a $4.78 billion sales drop-off to $9.08
billion. Harvoni’s global sales continued to
decline during the first six months of 2017,
coming in at $2.75 billion versus the 2016
first-half sum of $5.58 billion.
Harvoni is an oral formulation of ledip-asvir and sofosbuvir dosed once daily for
treating genotypes 1, 4, 5, and 6, HCV/
HIV-1 coinfection, HCV genotype 1 and 4
liver transplant recipients, and genotype
1-infected patients with decompensated
cirrhosis. In Europe, Harvoni is additionally available for certain patients with
HCV genotype 4 infection, HCV genotype
3 infection with cirrhosis and/or prior
treatment failure, and those with HCV/
During April 2017, FDA approved a
supplemental indication for Harvoni tab-
lets for treating HCV infection in adoles-
cents without cirrhosis or with compen-
sated cirrhosis, 12 years of age and older,
or weighing at least 35kg. Harvoni gained
U.S. approval for pediatric patients with
genotype 1, 4, 5, or 6 HCV infection.
Also in April, Gilead revealed positive
results from two Phase 2 studies evaluating Harvoni tablets in HCV-infected patient populations not previously studied in
dedicated clinical trials with direct-acting
antiviral therapies. The trials showed HCV
cure rates of 99 percent in children aged
6 to 11 years, and 100 percent in adult patients co-infected with HCV and HBV.
Remicade clocked in as the third best
seller in 2016 with sales of about $8.83
billion. Containing the active chemical in-fliximab, Remicade is used to treat a number of immune-mediated inflammatory
diseases. The TNF-α MAb is marketed
around the world via Johnson & Johnson,
Merck, and Mitsubishi Tanabe Pharma.
Remicade is experiencing biosimilar
competition in the United States and Europe. EvaluatePharma’s “World Preview
2017, Outlook to 2022” report predicts
sales of $2.74 billion in 2022 with a worldwide market share of 5 percent.
Like Remicade, Enbrel is a blockbuster brand competing in the immunology
marketplace that was launched in the
United States during 1998 and now faces
biosimilar competition. Enbrel (
etanercept) sales for 2016, generated between
Amgen, Pfizer and Takeda Pharmaceutical, reached nearly $8.5 billion. In second-quarter 2017, Enbrel sales for Amgen
decreased 1 percent due to the impact of
competition, offset partially by favorable
changes in inventory and net selling price
(Pfizer and Takeda’s Q2 2017 results for
Enbrel had not yet become available as
this magazine went to press).
EvaluatePharma analysis projects nearly $5.28 billion in sales for the TNF-α inhibitor Enbrel during 2022 with a global
market share of 9. 5 percent.
Sales during 2016 for Roche and Chugai
increased for the second consecutive calendar term, with about 3 percent year-over-year growth to SFr7.3 billion ($7.41
billion). Rituxan/MabThera is available
for common forms of blood cancer, rheumatoid arthritis and certain types of vas-culitis. Sales continued to rise despite
competitive pressure. According to Roche,
increasing demand was mainly evident
in China, the United States and Europe.
Growth in China was supported by expanded regional access, largely in diffuse
large B-cell lymphoma.
During June 2017, FDA approved Rit-
uxan Hycela (rituximab and hyaluroni-
dase human) for subcutaneous injection,
First-half 2017 sales for Rituxan/Mab-
Thera as reported by Roche rose 3 percent
to nearly SFr3.84 billion ($3.9 billion)
versus same-period 2016. Sales were bol-
stered by growth in the oncology and im-
munology segments. The largest sales in-
creases were recorded in the United States,
up 5 percent to SFr2.12 billion ($2.15 bil-
lion), and the International region, rising 7
percent to SFr658 million ($668 million).
Growth in China was supported by addi-
tional reimbursement approvals as well as
expanded regional access. EvaluatePhar-
ma has projected 2022 sales of $2.58 bil-
lion for Rituxan/Mab Thera.
Celgene’s Revlimid checked in as the
No. 6-ranked product in 2016 with sales
of $6.97 billion, accounting for a $1.17
billion improvement from 2015. Initially
approved by U.S. regulators in December
2005, the medicine is indicated for multiple myeloma, myelodysplastic syndromes,
and mantle cell lymphoma.
The oral immunomodulatory drug is
undergoing several phase III trials covering a range of hematological malignancies such as multiple myeloma, lymphomas and myelodysplastic syndromes. In
July 2017, the Phase III ROBUST study
testing Revlimid in combination with rituximab plus chemotherapy (R-CHOP)
in patients with ABC type diffuse large
B-cell lymphoma completed enrollment.
Data from the phase III ROBUST study
are anticipated during 2018.
Revlimid global sales during first-half
2017 rose 19. 7 percent on a reported
basis year-over-year to almost $3.92
billion. Based on the 2017 first-half performance, Celgene’s full-year 2017 guidance for the medicine ranges from $8.0
billion to $8.3 billion.
EvaluatePharma expects Revlimid will
be the world’s second-largest prescription
product in terms of sales during 2022. Ac-
cording to EvaluatePharma analysis, U.S.
sales will grow at an average of 15 percent
per year to about $10.15 billion in 2022,
with 13 percent CAGR globally during
2016-2022 to roughly $14.2 billion.
Sales for Roche’s anti-cancer agents
Avastin and Herceptin in 2016 continued to improve on a year-to-year basis. The
oncology drugs both produced SFr6.78
billion ($6.89 billion) in sales during last
year. In the first six months of 2017, Herceptin worldwide sales rose 3 percent to
SFr3.54 billion ($3.6 billion) and Avastin
sales declined 1 percent to nearly SFr3.41
billion ($3.46 billion).
Avastin is available for advanced colorectal, breast, lung, kidney, cervical and
ovarian cancer, and relapsed glioblastoma (a type of brain tumor). Herceptin is
used to treat HER2-positive breast cancer and HER2-positive metastatic (
advanced) gastric cancer.
For 2022, EvaluatePharma has projected that Avastin sales will amount to $4.35
billion and Herceptin’s total will come in
at about $3.65 billion.
Sanofi’s diabetes medicine Lantus
ranked ninth among all prescription drugs
in 2016 worldwide sales at almost € 5.71
billion ($6.33 billion), down by roughly
$1.38 billion compared to the product’s
2015 tally. For the first six months of 2017,
Lantus sales of € 2. 42 billion ($2.68 billion) decreased 16. 7 percent compared to
the first-half 2016 total. Biosimilar competition to the long-acting insulin is expected
to continue negatively impacting sales.
2016 global sales of $5.72 billion were
down for No. 10-ranked Prevnar 13/
Prevenar 13 compared to almost $6.25
billion during 2015 for the top-selling
vaccine worldwide. Prevnar 13 is FDA-approved for adults 18 years of age and older
for the prevention of pneumococcal pneumonia and invasive disease caused by 13
Streptococcus pneumoniae strains (1, 3, 4,
5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and
23F). According to Pfizer, Prevnar 13 is
the only pneumococcal vaccine approved
across the entire lifespan.
According to EvaluatePharma data,
Prevnar 13 worldwide sales are projected
to come in at almost $5.75 billion in 2022,
down 1 percent in terms of 2016-2022
CAGR, with global market share during
that time frame decreasing from 21. 9 percent to 16. 3 percent. medadnews
AbbVie’s biologic therapy Humira for autoimmune disorders
continues to dominate the sales landscape; Gilead’s once-daily
hepatitis C treatment Harvoni in 2016 repeated its performance
as the world’s second-best-selling prescription medicine.
Humira remains atop the throne