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Switching from reference products to biosimilars: the European perspective Posted 30/11/2018

The number of biosimilars receiving marketing authorization has grown steadily over the past several years [1, 2] and is expected to continue growing in the future. Particularly when biologicals are prescribed for the treatment of chronic diseases, switching patients from the originator biological to the biosimilar is increasingly becoming an option, allowing for a considerable reduction of public health expenditure. This article [3] provides an overview of current approaches in Europe to switching patients to treatment with biosimilars.

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have taken different positions on switching. According to draft US Food and Drug Administration (FDA) guidance on biosimilar interchangeability released in 2017 [4], an adequately powered switching study should be performed in a sensitive patient population for a biosimilar to gain interchangeability authorization. After approval is granted, the pharmacist may substitute the biosimilar for the reference product without consulting the prescriber, depending on individual state regulations [5].

In Europe, EMA has referred decisions about interchangeability or substitution to each Member State [6] and it was agreed that no further clinical studies are required to allow interchangeability, at variance from FDA. As yet, not every European country has released specific regulations on this matter but the general approach has been to allow, or even encourage, replacement of ongoing biological treatment with an approved biosimilar if performed under the supervision of a clinician. Even if automatic substitution at the pharmacy level is not recommended, lack of specific guidance or laws has made it possible to occur in some countries like Poland. In several Central and Eastern European countries pharmacy-level substitution has also been made possible with different modalities. Particularly in the Nordic countries massive non-medical switches with the supervision of prescribing physicians have taken place due mainly to purchase of biosimilars by bulk tenders [7].

As a result, large amounts of clinical data from post-marketing or registry studies are being generated regarding the effects of transitioning patients to biosimilar treatment [8-10]. Data collected so far have tended to indicate that switching is safe and does not lead to loss of therapeutic efficacy. Important drawbacks of such studies are represented by lack of long-term follow up, small size, lack of immunogenicity data, and lack of data on multiple switches. There have been some reports of higher discontinuation rates from treatment with either infliximab or etanercept after non-medical switch due to patient-reported loss of effect or adverse events that need to be further investigated. A potential nocebo effect has been claimed to explain this phenomenon since the majority of patients discontinuing treatment with a biosimilar did not show objective signs of reduced efficacy or safety issues. Recent studies also point to the importance of sharing clear and exhaustive information with patients regarding the characteristics of biosimilars.

In conclusion, based on accumulating favourable data on biosimilars use and due to the need for containing health expenditures, there is a growing tendency in Europe to favour non-medical switching from reference products to biosimilars. It is believed, however, that a successful switch should be based on two main factors: reliable and solid information for patients and collaboration among all stakeholders. For this reason, it is crucial that larger-scale studies be conducted to better assess the long-term effects of switching on safety and immunogenicity. At the same time, collaborative switching programmes should be implemented that can provide the patients with adequate information to gain their confidence and to avoid any potential nocebo effect.

Conflict of interest
The authors of the research paper [3] declared that there was no conflict of interest. Authors are employees of Syneos Health.

Abstracted by Anna La Noce, MD, Executive Medical Director, General Medicine, Syneos Health.

Editor’s comment
Readers interested to learn more about switching to biosimilars are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal

Randomized non-inferiority trial fails to find inferiority switching from infliximab originator to CT-P13 biosimilar

Switching from the infliximab reference product to CT-P13 in patients with rheumatoid arthritis or ankylosing spondylitis: results of the PLANETAS and PLANETRA extension studies

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Related article
Biosimilars penetration in Europe varies widely

References
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2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 30]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
3. La Noce A, Ernst M. Switching from reference to biosimilar products: an overview of the European approach and real-world experience so far. EMJ. 2018;3(3):74-81.
4. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on biosimilar interchangeability [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 30]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-on-biosimilar-interchangeability
5. Derbyshire M. Update on US state legislation on biosimilars substitution. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(2):95-7. doi:10.5639/gabij.2015.0402.020
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilar substitution in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 30]. Available from: www.gabionline.net/Reports/Biosimilar-substitution-in-Europe
7. GaBI Online - Generics and Biosimilars Initiative. Switching approaches to biosimilars in Nordic countries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 30]. Available from: www.gabionline.net/Reports/Switching-approaches-to-biosimilars-in-Nordic-countries
8. GaBI Online - Generics and Biosimilars Initiative. NOR-SWITCH study finds biosimilar infliximab not inferior to originator [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 30]. Available from: www.gabionline.net/Biosimilars/Research/NOR-SWITCH-study-finds-biosimilar-infliximab-not-inferior-to-originator
9. GaBI Online - Generics and Biosimilars Initiative. Danish infliximab switching study shows no difference [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 30]. Available from: www.gabionline.net/Biosimilars/Research/Danish-infliximab-switching-study-shows-no-difference
10. GaBI Online - Generics and Biosimilars Initiative. Real world switching data for etanercept biosimilar Benepali [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 30]. Available from: www.gabionline.net/Biosimilars/Research/Real-world-switching-data-for-etanercept-biosimilar-Benepali

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