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Features May 21, 2019

The top selling prescription drugs by revenue

Humira tops the list despite growing biosimilar competition, while Opdivo and Keytruda, the new-age checkpoint
inhibitors for cancer have grown in terms of market share and revenue generation since their approval in 2014.
Pharmaceutical-technology.com lists the top-selling prescription drugs based on sales.

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Humira generated approximately 61% of the total net revenues of Abbvie in 2018. Credit: Lyza.
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 Roche S.A.

Novartis AG
9. Opdivo (nivolumab)
Takeda Oy
8. Eylea (aflibercept)
Celgene Corp
7. Avastin (bevacizumab)
Janssen Inc
6. Herceptin (trastuzumab)
View All

5. Enbrel (etanercept)

4. Keytruda (pembrolizumab)

3. Revlimid (lenalidomide)

2. Eliquis (apixaban)

1. Humira (adalimumab)

10. Xarelto (rivaroxaban) – $6.5bn

top selling prescription drugs

The oral coagulant drug Xarelto’s sales are declining in the US year on year. Image courtesy of
Newswire.

Developed by Johnson & Johnson (J&J) and Bayer, Xarelto recorded a worldwide
sales growth of 5% in 2018 compared to 2017. It is the only oral coagulant approved in
both the US and Europe to treat coronary artery disease (CAD) and peripheral artery
disease.

Xarelto has remained Bayer’s best-selling product in the pharmaceuticals segment in

2018 driven by higher sales volumes in Europe, China and Canada. The drug’s sales in the
US, where it is marketed by J&J, are however declining year-on-year due to higher
discounts provided to healthcare providers and government channels.

Bayer is facing several lawsuits in the US from approximately 24,900 recipients alleging
personal injuries, including cerebral and gastrointestinal bleeding, and even death due to
the use of the drug. The company has refuted the claims and filed a motion for leave to
appeal.

Xarelto’s patent is set to expire in 2024 exposing it to generic competition. The

developers are focussing on expanding the indications for the drug to address the
competition. The drug was approved as a combination therapy with acetylsalicylic acid
for the prevention of atherothrombotic events in adults with CAD in Europe and the US.
J&J’s subsidiary Janssen has also submitted a supplemental new drug application for the
prevention of venous thromboembolism.

9. Opdivo (nivolumab) – $6.7bn

 top selling prescription drugs

Opdivo’s net sales grew by 36% worldwide in 2018. Photo: Business Wire.

Opdivo is the world’s first-approved anti-programmed death receptor (PD-1) developed

by Bristol Myers Squibb (BMS). Sales of Opdivo rose by 36% worldwide in 2018 and by
37% in the US.

The immunotherapy drug was first approved in Japan and then in the US in 2014.
Currently, Opdivo is approved for the treatment of 12 types of cancer either as
monotherapy or as a combination drug.

The drug is also the first immuno-oncology agent to receive approval in China for the
treatment of previously-treated non-small cell lung cancer (NSCLC), which expanded its
market in China.

Opdivo will go off-patent in Europe in 2026 and in 2027 in the US. The drug is being
evaluated in combination with Yervoy as a promising treatment for various cancer
indications.

8. Eylea (aflibercept) – $6.7bn

top selling prescription drugs

Regeneron and Bayer are co-developing Eylea for the treatment of ophthalmic conditions.
Image courtesy of Clappstar.

Eylea is approved for the treatment of wet macular degeneration in the US, Europe, and
Australia. In Japan, the drug is approved for the treatment of macular oedema secondary
to retinal vein occlusion. The increase in sales of the drug outside the US boosted the
global sales of the drug by 12% in 2018 compared to 2017.

First launched in 2011, Eylea is being co-developed by Regeneron and Bayer for the
treatment of ophthalmic conditions, under an agreement signed in 2006. Regeneron is
also developing the drug for cancer treatment, along with Sanofi.

Eylea’s market share is expected to improve due to its label expansion for diabetic
retinopathy treatment in the US. Approximately, eight million people suffer from diabetic
retinopathy worldwide and it is a leading cause of blindness in the US. Patent protection
for Eylea will expire in the US in 2020, followed by 2012 in Europe.

7. Avastin (bevacizumab) – $6.9bn

 top selling prescription drugs

Broader market penetration in China increased the Avastin’s sales in the international market.
Image courtesy of Marco Verch.

Developed by Roche, Avastin’s net sales grew by 3% worldwide supported by a 12%

growth in the international market especially due to broader market penetration in China

The increased demand for ovarian cancer treatment in Japan resulted in a 3% growth in
sales in Japan, while the European sales declined by 1% due to a reduction in the
reimbursement for the drug.

First approved in 2004, Avastin is currently approved to treat six types of cancers,
including advanced lung, colorectal, kidney, cervical, ovarian cancer and relapsed
glioblastoma. Patent protection for the drug will expire in the US in July 2019 and in
Europe in 2022.

6. Herceptin (trastuzumab) – $7bn

top selling prescription drugs

Biosimilar competition declined Herceptin’s net sales in Europe and Japan in 2018. Image
courtesy of Roche.

Biosimilars competition negatively impacted the sales of Roche’s Herceptin in Europe and
Japan as a 16% sales decline was observed in both regions. Price cuts by the government
in Japan also added to the decline.

First approved in 1998 as the first drug to treat HER2-positive breast cancer, Herceptin is
also currently approved for the treatment of metastatic breast cancer and gastric cancer.
Herceptin sales grew by 1% in 2018 due to the growth in the US and in China, but the way
ahead is expected to be tough as four biosimilars have already been approved and the US
patent for the drug is set to expire in 2019.

5. Enbrel (etanercept) – $7.1bn

 top selling prescription drugs

Enbrel’s net sales dipped by 8% due to lower unit demand and net selling price in 2018. Image
courtesy of Amgen.

Amgen’s Enbrel reported consolidated net sales of $5bn in the US and Canada, while
Pfizer reported $2.1bn sales in the Rest-of-the-World (RoW) region. In Japan, Pfizer
markets Enbrel in partnership with the Japanese pharmaceutical company Takeda.

The drug is facing increasing biosimilar competition in the European markets, which is
negatively impacting the drug’s operation worldwide. It is also facing growing
competition from other branded drugs. Enbrel competes with Johnson & Johnson’s
Remicade and Stelara, AbbVie’s Humira, and Celgene’s Otezla in the US and Canada. The
net sales of the drug dipped by 8% in 2018 compared to 2017 due to lower unit demand
and net selling price.

Enbrel was launched in 1998 for the treatment of rheumatoid arthritis, plaque psoriasis,
and psoriatic arthritis. Multiple US patents of Enbrel will expire in 2019, 2023, 2028, and
2029. Novartis’ generic division, Sandoz is already in pursuit of marketing a biosimilar for
the drug named Erelzi™ in the US market, against which Amgen has filed a lawsuit for
patent infringement.

4. Keytruda (pembrolizumab) – $7.1bn

top selling prescription drugs

Keytruda is approved for the treatment of 11 types of cancer. Image courtesy of Merck.

Net sales of Merck’s Keytruda grew by approximately 47% in 2018 owing to approval in
multiple indications. The drug is approved for the treatment of 11 types of cancer,
including non-small cell lung cancer, head and neck squamous cell carcinoma, melanoma
and cervical cancer either as a monotherapy in combination with other therapies.

Keytruda was the first anti-PD-1 therapy approved by the US Food and Drug
Administration (FDA) in 2014. The drug is currently being studied for the treatment of
several indications and has submitted various supplemental biologics licence applications
(sBLA). The drug will go off-patent in 2028 in the US and Europe, as well as in 2032 in
Japan.

The drug was approved as a first-line treatment for NSCLC by the Chinese National
Medical Products Administration (NMPA) in 2019 marking its entry into the Chinese
market. The approval provides a competitive edge over BMS’ Opdivo, a close competitor,
which is already approved as a second-line treatment of NSCLC in the country.

3. Revlimid (lenalidomide) – $9.7bn

top selling prescription drugs

Revlimid net sales increased by approximately 18% in 2018. Image courtesy of Celgene.

In 2018, Celgene’s Revlimid recorded approximately an 18% year-over-year growth in net

sales driven by increased treatment duration and market share. Investments in research
and development for label expansion either as monotherapy or in combination have
helped the company in maintaining its revenues.

Initially approved in 2005, the drug is indicated to treat multiple myeloma,

myelodysplastic syndromes, and mantle cell lymphoma.

The drug has shown encouraging results in various clinical developments for the
treatment of newly diagnosed multiple myeloma, relapsed/refractory non-Hodgkin
lymphoma, and diffuse large B-cell lymphoma (DLBCL), which serves as potential growth
drivers across geographies in future. The drug is currently under late-stage clinical
development for follicular lymphoma, indolent lymphoma, and untreated activated B-cell
DLBCL.

2. Eliquis (apixaban) – $9.8bn

top selling prescription drugs

Eliquis is a part of Novel Oral anticoagulant (NOAC) market. Image courtesy of Bristol Myers
Squibb.

Eliquis is one of the strong and growing franchises of BMS with a 32% growth in net sales
in 2018. It was jointly developed and commercialised by BMS and Pfizer, with the latter
contributing 50% to 60% of the development cost of the drug.

Pfizer reported a 36% growth in the net sales of the drug worldwide. Initially launched in
2012, the drug is a factor Xa inhibitor anticoagulant approved to reduce stroke and
systemic embolism risk in patients with non-valvular atrial fibrillation.

The increased adoption of non-valvular atrial fibrillation and oral anti-coagulant

worldwide is the driving force for the growing market share of the drug. The US patent of
the drug is set to expire in 2023.
1. Humira (adalimumab) – $19.9bn
top selling prescription drugs

Humira generated approximately 61% of the total net revenues of Abbvie in 2018. Credit: Lyza.

Humira is Abbvie’s single largest product and its net sales grew by 7% worldwide in 2018,
despite the launch of biosimilars in various parts of the world. The drug accounted for
approximately 61% of the total net revenues of the company in 2018.

The growth is primarily attributed to an increase in the market across different

therapeutic indications and geographies as well as favourable pricing in various
geographies.

Humira is approved for the treatment of several autoimmune diseases, including

rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ankylosing spondylitis, and
plaque psoriasis in the US, Canada, Mexico, and Europe.

It is also approved in Japan for the treatment of intestinal Behcet’s disease and
commercialised in various other markets worldwide such as China, Brazil and Australia.
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