Table 4.
Rank | Product | Sales, 2021 ($ billions)a | Year first approved | Company | Patent expiryb | Biosimilar version(s) approved |
---|---|---|---|---|---|---|
1 | Comirnaty (COVID-19 Vaccine, mRNA) | 36.8 | 2020c | Pfizer & BioNTech | N/A | |
2 | Humira (adalimumab) | 21.2 | 2002 | AbbVie & Eisai |
2016 (US) 2018 (EU) |
Halimatoz/Hefiya/Hyrimoz, Amgevita/Amjevita/Solymbic, Cyltezo, Imraldi, Kromeya, Idacio, Hadlima, Abrilada, Hulio, Amsparity, Yusimry, Yuflyma, Libmyris, Hukyndra |
3 | Spikevax (COVID-19 Vaccine, mRNA) | 17.7 | 2020c | Moderna | N/A | |
4 | Keytruda (pembrolizumab) | 17.2 | 2014 | Merck |
2036 (US) 2028 (EU) |
|
5 | Stelara (ustekinumab) | 9.5 | 2009 | Janssen (Johnson & Johnson) |
2023 (US) 2024 (EU) |
|
6 | Eylea (aflibercept) | 9.4 | 2011 | Regeneron, Bayer | 2027 (EU & US) | |
7 | Opdivo (nivolumab) | 8.5 | 2014 | BMS, Ono |
2027 (US) 2026 (EU) |
|
8 | Ronapreve/Regen-Cov (casirivimab & imdevimab) | 7.6 | 2020 | Roche, Regeneron | N/A | |
9 | Trulicity (dulaglutide) | 6.7 | 2014 | Eli Lilly |
2026 (US) 2024 (EU) |
|
10 | Darzalex (daratumumab) | 6.0 | 2015 | Janssen |
2027 (US) 2026 (EU) |
|
11 | Dupixent (dupilumab) | 5.9 | 2017 | Sanofi-Aventis, Regeneron | N/A | |
12/13 | Prolia/Xgeva (denosumab) | 5.7 | 2010 | Amgen |
2025 (US) 2022 (EU) |
|
12/13 | Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) | 5.7 | 2014 | Merck | 2028 (US & EU) | |
14 | Enbrel (etanercept) | 5.6 | 1998 | Amgen, Pfizer, Takeda Pharmaceuticals | 2015 (EU) 2028 (US) | Erelzi, Benepali/Eticovo, Nepexto |
15 | Ocrevus (ocrelizumab) | 5.5 | 2017 | Roche/Genentech |
2027 (EU) 2029 (US) |
|
16 | Cosentyx (secukinumab) | 4.7 | 2015 | Novartis |
2026 (US) N/A (EU) |
|
17 | Entyvio (vedolizumab) | 4.4 | 2014 | Takeda |
2026 (US) N/A (EU) |
|
18 | Perjeta (pertuzumab) | 4.3 | 2012 | Roche/Genentech |
2024 (US) 2023 (EU) |
|
19 | Soliris (eculizumab) | 4.2 | 2007 | Alexion |
2027 (US) 2020 (EU) |
|
20 | Lantus/Toujeo (insulin glargine) | 3.9 | 2000 | Sanofi | 2014 (EU & US) | Semglee, Lusduna, Abasaglar, Rezoglar |
aFinancial data from LaMerie Business Intelligence and Fierce Pharma.
bPatent data from various sources, predominantly http://gabi-journal.net/. Note that patent landscape for biologics can be particularly complex: issues such as follow-on patents subsequent to the main patent and patent litigation can delay biosimilar development and approval. cInitial date of Emergency Use Authorization or Conditional Marketing Authorisation.
N/A, data not available.