Biosimilars in the US and Europe
Biosimilars in the US and Europe
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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.
Author: Tim Wesley
Publisher: Datamonitor Healthcare
- Description
- Contents
Second-wave fireworks or a damp squib?
Price and access woes prompt a rethink by biosimilar investors
- Second-generation biosimilars are struggling to make inroads into the US market, while investors in the sector are pocketing lower-than-expected returns in Europe, where prices have fallen further and more rapidly than anticipated. We should be in the midst of a biosimilars boom. Instead, the past 18 months has seen a series of players exit the sector completely or scale back their involvement. Others are reconsidering commercial models that were built to fit a very different market environment.
- Frustrated by recent developments, the biosimilars lobby is calling on policymakers in both the US and Europe to address issues that they say pose a real danger to long-term investment in a sector long heralded as a potential savior for cash-strapped healthcare systems. In the US, lawmakers are debating measures designed to tackle originator patenting and rebating strategies that have delayed the entry of most second-generation biosimilars and limited the impact of those which have made it to market. In Europe, meanwhile, players in the sector have warned governments and payers that procurement and pricing mechanisms designed to maximize savings on multi-source biologics threaten to undermine the commercial viability of biosimilars.
Second wave makes a splash in Europe – but not in the US
- Composition-of-matter patents on the eight blockbusting biologic molecules profiled in this study – including insulin analogs, TNF inhibitors, and monoclonal antibody-based cancer treatments – have expired in the US and Europe since 2013. Regulators on both sides of the Atlantic have approved follow-on versions of all eight products, but while seven originators have been exposed to biosimilar competition in Europe, the figure stands at just three in the US, where patent fortresses built around some original brands have proved impenetrable.
- The ability of originators to delay biosimilar launches means payers and patients in the US are still paying top dollar for drugs that have declined dramatically in price across Europe. Between 2014 and 2018, aggregate sales generated by the eight original brands in Europe fell by almost $5.7bn (32.6%). During the same period, their combined US revenues rose by more than $5.1bn, or 16.5%.
- Even where biosimilars have reached the US market, few have gained significant traction, with originator rebating strategies and payer/provider economics mitigating against more widespread uptake. Remicade (infliximab) still held a 93% volume share of the US market two years after the launch of the country’s first infliximab biosimilar, for example, during which time the brand’s US revenues fell by only 24%. By contrast, Remicade’s European revenues halved in the two years following its exposure to competition from infliximab biosimilars, which captured majority volume shares of some markets in the region within a matter of months.
Humira highlights the transatlantic biosimilars gulf
- Developments in the market for the world’s best-selling drug, Humira (adalimumab), encapsulate the dramatic differences between the environment facing biosimilar developers in the US and Europe – and the problems they face on both sides of the Atlantic.
- In Europe, the simultaneous launch of four biosimilar adalimumab products has triggered an intense battle for market shares. Heavy discounting has seen adalimumab prices plummet by up to 80% in some countries and has driven a sharper-than-anticipated decline in Humira’s sales. Revenues being achieved by early biosimilar entrants are also lower than anticipated, however, and latecomers to the market could struggle to generate significant returns on products that will have been earmarked for years as the biggest potential contributors to their biosimilar businesses.
- While adalimumab prices are tumbling across Europe, AbbVie raised Humira’s US sticker price by almost 10% in 2018, and posted an increase of similar proportions – to $13.7bn – in the brand’s US revenues. It announced a further 6.2% list price increase at the beginning of 2019, and will be at liberty to implement regular additional hikes for more than three years, having settled patent infringement proceedings with a slew of biosimilar developers that will see Humira retain US market exclusivity until the beginning of 2023.
- When adalimumab biosimilars do eventually reach the US market, Amgen will enjoy a brief but valuable first-mover advantage bestowed upon it by AbbVie. As many as eight competing follow-on products could have been launched by the end of 2023, however, and latecomers will be forced to enter a market where the biggest spoils have already been won.
A tipping point for the biosimilars market?
- First biosimilar versions of Avastin (bevacizumab), Herceptin (trastuzumab), and Rituxan (rituximab) are all expected to reach the US market during the second half of 2019. Those three brands generated combined US sales of $10.3bn in 2018.
- With biosimilar prices in Europe falling well below expectations, and other key targets such as Humira and Enbrel (etanercept) remaining off limits in the US, the performance of bevacizumab, trastuzumab, and rituximab biosimilars in the world’s biggest market over the next two to three years could have a major bearing on the future of the sector. If they disappoint, prospects for long-term investment in the biosimilars space could be thrown into serious doubt. If they generate substantial revenues at reasonable prices, however, they could finally kickstart the US biosimilars market, cementing the commitment of existing players and acting as a catalyst for new investment in the sector.
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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