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Top 8 blockbuster biologicals 2013 Posted 06/06/2014

The top three best-selling drugs during 2013 were biologicals. All three best-sellers are indicated for the treatment of arthritis, and include Abbott’s Humira (adalimumab), Merck’s Remicade (infliximab) and Roche’s Rituxan/MabThera (rituximab).

In fact, seven of the top eight best-selling drugs for 2013 were biologicals and eight of the top 15 were also biologicals, see Table 1.

All the biologicals on the 2013 list had increased sales compared with 2012. The biggest sales increases were for Sanofi’s diabetes treatment Lantus (insulin glargine) and Abbott’s arthritis treatment Humira, with sales increases of 15.2% and 15%, respectively, compared to 2012.

Biologicals to treat cancer also represented three of the top eight best-sellers, and included Rituxan (Non-Hodgkin’s lymphoma), Herceptin (breast cancer) and Avastin (colorectal, lung and kidney cancer).

Six of the top eight blockbuster biologicals are antibodies, the top selling therapeutic proteins are insulin glargine and pegfilgrastim. The anti-TNF antibody Humira (adalimumab) is the top selling single brand of a recombinant biological with 2013 sales of US$10.7 billion, up from US$9.5 in 2012 [1], see Table 1.

Table 1: Top 8 blockbuster biologicals 2013

Brand name

Active ingredient

Type

Class

Treatment

Company

2013 global sales

(US$ billion)

Patent expiry

EU/US [2]

Humira

adalimumab

Antibody

TNF inhibitor

Arthritis

Abbott/Eisai

10.7

Apr 2018/ Dec 2016

Remicade

infliximab

Antibody

TNF inhibitor

Arthritis

Merck/Mitsubishi

8.9

Aug 2014/ Sep 2018

Rituxan/MabThera

rituximab

Antibody

Anti-CD20

Arthritis, NHL

Roche/Biogen-Idec

8.6

Nov 2013/ Dec 2018

Enbrel

etanercept

Antibody

TNF inhibitor

Arthritis

Amgen/Pfizer/Takeda

8.3

Feb 2015/ Nov 2028

Lantus

insulin glargine

Protein

Insulin receptor

Diabetes

Sanofi

7.8

2014/2014

Avastin

bevacizumab

Antibody

Anti-angiogenesis

Cancer

Roche

7.0

Jan 2022/ Jul 2019

Herceptin

trastuzumab

Antibody

Anti-HER2

Breast cancer

Roche

6.8

Jul 2014/ Jun 2019

Neulasta

pegfilgrastim

Protein

G-CSF

Neutropenia

Amgen

4.4

Aug 2017/ Oct 2015

NHL = Non-Hodgkin’s lymphoma

The patents on almost all of these biological blockbusters will have expired by 2020, apart from Enbrel (etanercept) where the US patent has been extended to 2028 [3]. Considering just these eight biologicals, this will open up around US$63 billion in sales to competition from biosimilars. The biosimilars market earned revenue of approximately US$172 million in 2010 and with global sales of biologicals on the rise, this can only increase.

Related articles

US approvals of biologicals doubled in last decade

2012’s biggest patent expiries

References

1. GaBI Online - Generics and Biosimilars Initiative. Biologicals sales have almost doubled since 2006 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 6]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-sales-have-almost-doubled-since-2006

2. GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 6]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020

3. GaBI Online - Generics and Biosimilars Initiative. New Amgen Enbrel patent could block biosimilars until 2028 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 6]. Available from: www.gabionline.net/Biosimilars/News/New-Amgen-Enbrel-patent-could-block-biosimilars-until-2028

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Source: Genetic Engineering News

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