The US still lags behind Europe when it comes to biosimilar approvals and uptake. There are currently 73 biosimilars approved in Europe, almost all of which were marketed immediately after approval [2]. In contrast, the US Food and Drug Administration (FDA) has approved only 29 biosimilars [3], with only 18 of these having been launched in the country [4].

The uptake of biosimilars does vary between different countries in Europe. Therefore, targets and incentives have been used across Europe in order to encourage the use of biosimilars [5].

For example, France and the UK have both set targets of reaching 80% biosimilar utilization. France set its target of reaching 80% biosimilar penetration by 2022 as part of the country’s 2018−2022 National Health Strategy and represents an increase from the previous target of 70% [6].

While some countries have required the use of biosimilars, other strategies for meeting targets have been helpful in encouraging biosimilar uptake. These include incentives for providers to prescribe biosimilars as well as sharing benefits with patients, also known as gainsharing.

Germany and the UK are among more than a dozen countries across Europe that offer provider incentives to prescribe biosimilars. While France and the UK have also created programmes to share the benefits of biosimilar savings with patients.

For example, both Germany and Sweden have established gain-sharing arrangements at the payer level [7, 8]. While in the UK, NHS England offers providers 1% of the contract value of biosimilars if they start 90% of new patients on a biosimilar and switch 80% of existing patients. Irish hospitals have also been offered incentives to switch patients to biosimilars. They have been offered a 500 Euro incentive for every patient they switch from two expensive biologicals to cheaper biosimilars [9].

In the US pharmacy benefits management (PBM) companies (third party administrators of prescription drug programmes) have reported that their efforts have resulted in infliximab utilization of 75%‒90%. However, the former FDA Commissioner Dr Scott Gottlieb has said that the drug contracting system in the US is ‘rigged’ against biosimilars. He pointed out that PBMs have a significant financial incentive to limit the uptake of biosimilars to continue the flow of large rebate payments. Likewise, health plans have a big disincentive to switch to the biosimilar, as by doing so they will lose the incumbent rebates paid on the originator biological [10].

The authors of the report concluded that the US ‘healthcare system, including government programs, should push this kind of biosimilar initiative’ and ‘should also consider sharing biosimilar savings’ … ‘with providers and patients’. They added that ‘shared savings programs have become common in Medicare^# and could be extended to biosimilars, while private health plans could set up their own shared savings programs’.

#Medicare is a national social insurance programme, administered by the US federal government since 1966. It provides health insurance for Americans aged 65 and older who have worked and paid into the system, as well as to younger people with disabilities.

Related articles
Drug regulators need to evolve with biosimilars

Confidence in clinical evidence and switching data for biosimilars 

Education for biosimilars in Europe and the US

Price controls, competition and pricing for biosimilars

How do the biosimilar markets in the US and Europe compare?

What can the US learn from the European biosimilars market?

References
1. Biosimilars Council. Brill A, Robinson C. Lessons for the United States from Europe’s biosimilar experience. June 2020 [homepage on the Internet]. [cited 2021 Feb 5]. Available from: https://biosimilarscouncil.org/resource/europes-biosimilar-experience/ 
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe 
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US 
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilar approvals and launches in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Biosimilars/General/Biosimilar-approvals-and-launches-in-the-US 
5. GaBI Online - Generics and Biosimilars Initiative. Uptake of biosimilars in different countries varies [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Reports/Uptake-of-biosimilars-in-different-countries-varies 
6. GaBI Online - Generics and Biosimilars Initiative. France aims to reach 80% biosimilar penetration by 2022 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Policies-Legislation/France-aims-to-reach-80-biosimilar-penetration-by-2022 
7. GaBI Online - Generics and Biosimilars Initiative. Influence of local policy measures and practices on biosimilar/originator market dynamics in Germany [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Biosimilars/Research/Influence-of-local-policy-measures-and-practices-on-biosimilar-originator-market-dynamics-in-Germany 
8. GaBI Online - Generics and Biosimilars Initiative. How local policy measures and practices influence originator biological and biosimilar market dynamics in Sweden [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Biosimilars/Research/How-local-policy-measures-and-practices-influence-originator-biological-and-biosimilar-market-dynamics-in-Sweden 
9. GaBI Online - Generics and Biosimilars Initiative. Irish hospitals to get incentives to switch patients to biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Biosimilars/General/Irish-hospitals-to-get-incentives-to-switch-patients-to-biosimilars 
10. GaBI Online - Generics and Biosimilars Initiative. US drug contracting system is ‘rigged’ against biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Biosimilars/General/US-drug-contracting-system-is-rigged-against-biosimilars

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2021 Pro Pharma Communications International. All Rights Reserved.