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Biosimilars have been available in Europe for over a decade, and have offered the opportunity to vastly reduce the cost of treatment for a large number of biologic agents.
Second-wave fireworks or a damp squib?
CONTENTS
7 OVERVIEW
7 Price and access woes prompt a rethink by biosimilar investors
7 Second wave makes a splash in Europe – but not in the US
7 Humira highlights the transatlantic biosimilars gulf
8 A tipping point for the biosimilars market?
9 BIOSIMILARS: THE ROAD TO MARKET IN THE US AND EUROPE
10 Regulatory hurdles for biosimilars are high
11 Biosimilar pricing and reimbursement rules vary
12 The first generation and the second wave
15 First-generation biosimilar takeaways in Europe
19 Early biosimilar takeaways in the US
23 The second biosimilar wave
23 Bibliography
27 INSULIN GLARGINE
27 Patent expiry and the arrival of biosimilar insulin glargine
29 Post-biosimilar development of the US market for insulin glargine
32 Post-biosimilar development of the EU market for insulin glargine
37 Bibliography
41 INSULIN LISPRO
41 Patent expiry and the arrival of biosimilar insulin lispro
42 Post-biosimilar development of the US market for insulin lispro
44 Post-biosimilar development of the EU market for insulin lispro
47 Bibliography
50 ETANERCEPT
50 Patent expiry and the arrival of biosimilar etanercept
51 Post-biosimilar development of the US market for etanercept
52 Post-biosimilar development of the EU market for etanercept
57 Bibliography
62 INFLIXIMAB
62 Patent expiry and the arrival of biosimilar infliximab
64 Post-biosimilar development of the US market for infliximab
68 Post-biosimilar development of the EU market for infliximab
74 Bibliography
79 ADALIMUMAB
79 Patent expiry and the arrival of biosimilar adalimumab
82 Post-biosimilar development of the US market for adalimumab
83 Post-biosimilar development of the EU market for adalimumab
88 Bibliography
92 BEVACIZUMAB
92 Patent expiry and the arrival of biosimilar bevacizumab
94 US will be the key target for early biosimilar entrants
95 Bibliography
97 TRASTUZUMAB
97 Patent expiry and the arrival of biosimilar trastuzumab
99 Post-biosimilar development of the US market for trastuzumab
101 Post-biosimilar development of the EU market for trastuzumab
105 Bibliography
108 RITUXIMAB
108 Patent expiry and the arrival of biosimilar rituximab
110 Post-biosimilar development of the US market for rituximab
112 Post-biosimilar development of the EU market for rituximab
116 Bibliography
119 THE OUTLOOK FOR BIOSIMILARS IN THE US AND EUROPE
119 High hopes for the second biosimilar wave
121 Is the commercial model for biosimilars is faltering?
124 Is a “golden age” passing biosimilar investors by?
129 Fixing biosimilar industry issues
133 Who will stay the biosimilars course?
137 Bibliography
142 APPENDIX
142 About the author
142 Scope
142 Methodology
LIST OF TABLES
10 Table 1: EU and US biosimilar approvals by year
14 Table 2: First biosimilar approvals by molecule in Europe and the US
16 Table 3: Neupogen ex-US revenues, 2008–14
18 Table 4: Biosimilar shares of 5EU markets for filgrastim
19 Table 5: First-generation biosimilars: key lessons learnt in Europe
20 Table 6: Biosimilar approvals and launches in the US
23 Table 7: First-generation biosimilars: key lessons learnt in the US
28 Table 8: Biosimilar insulin glargine approvals and launches in the US and EU
31 Table 9: Insulin glargine product sales in the US, 2014–18
32 Table 10: Basaglar US sales by quarter since launch
33 Table 11: Insulin glargine product sales in Europe, 2014–18
34 Table 12: Volume share of 5EU markets for insulin glargine 100 U/ml, 2017
35 Table 13: Shares of the German insulin glargine market by product, 2018
41 Table 14: Global sales of original short-acting insulin analog brands, 2018
43 Table 15: US sales of short-acting insulin analog products, 2017–18
45 Table 16: European market for short-acting insulin analog products, 2018
46 Table 17: German payer spending on insulin lispro products, 2018
50 Table 18: Global Enbrel revenues, 2012–18
52 Table 19: Amgen’s US Enbrel revenues, 2014–18
53 Table 20: European sales of Benepali, 2016–18
54 Table 21: Enbrel sales in Europe, 2014–18
55 Table 22: Volume shares of 5EU markets for etanercept, 2017
56 Table 23: Etanercept usage and spending in Germany, 2018
62 Table 24: Remicade revenues reported by Johnson & Johnson and Merck & Co, 2014–18
63 Table 25: Infliximab biosimilar approvals and launches in Europe
64 Table 26: Infliximab biosimilar approvals and launches in the US
66 Table 27: Remicade’s US sales, 2014–18
67 Table 28: Inflectra’s US sales by quarter since launch
69 Table 29: Remicade’s European sales, 2014–18
71 Table 30: Volume shares of 5EU markets for infliximab, 2017
72 Table 31: European infliximab product sales, 2016–18
79 Table 32: Humira global revenues, 2014–18
80 Table 33: Biosimilar adalimumab approvals and product launch status in the EU
81 Table 34: Settlements governing the commercialization of adalimumab biosimilars in the US
82 Table 35: US sales of Humira, 2014–18
84 Table 36: Humira Q1 sales, 2018 and 2019
87 Table 37: NHS England regional adalimumab tender awards for 2019
92 Table 38: Avastin global revenues, 2014–18
93 Table 39: Bevacizumab biosimilars approved by US and EU regulators
94 Table 40: Avastin US revenues, 2014–18
97 Table 41: Herceptin global revenues, 2014–18
98 Table 42: Biosimilar trastuzumab approvals and launch status in the EU
99 Table 43: Biosimilar trastuzumab approvals in the US
101 Table 44: Herceptin US revenues, 2014–18
102 Table 45: Herceptin European revenues, 2014–18
104 Table 46: Herceptin European sales by quarter, 2017–19
108 Table 47: MabThera/Rituxan global revenues by area of indication, 2014–18
110 Table 48: Biosimilar rituximab approval and launch status in the US and Europe
111 Table 49: Rituxan US revenues, 2014–18
113 Table 50: Volume shares of 5EU markets for intravenous rituximab, 2017
115 Table 51: MabThera European revenues, 2014–18
116 Table 52: MabThera European sales by quarter, 2017–19
120 Table 53: Impact of biosimilar competition on originator revenues in Europe
121 Table 54: Impact of biosimilar competition on originator revenues in the US
128 Table 55: Major biologic patent expiry dates to 2025
134 Table 56: Big Pharma involvement in the US and European biosimilar markets
136 Table 57: Biosimilar exits and divestments
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