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
Source: www.gabionline.net
