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Review
. 2017 Jun;19(6):37.
doi: 10.1007/s11926-017-0658-4.

Switching Between Reference Biologics and Biosimilars for the Treatment of Rheumatology, Gastroenterology, and Dermatology Inflammatory Conditions: Considerations for the Clinician

Robert Moots  1   2 , Valderilio Azevedo  3 , Javier L Coindreau  4 , Thomas Dörner  5 , Ehab Mahgoub  4 , Eduardo Mysler  6 , Morton Scheinberg  7 , Lisa Marshall  4
Affiliations
Review

Switching Between Reference Biologics and Biosimilars for the Treatment of Rheumatology, Gastroenterology, and Dermatology Inflammatory Conditions: Considerations for the Clinician

Robert Moots et al. Curr Rheumatol Rep. 2017 Jun.

Abstract

Purpose of review: Biosimilars of the reference biologic therapeutics infliximab, etanercept, adalimumab, and rituximab are entering the market. Clinical and real-world data on the effects of reference → biosimilar switching are limited. This review was carried out to assess the current body of switching data.

Recent findings: Fifty-three switching studies were identified. Infliximab publications covered CT-P13 (25 studies), SB2 (1), infliximab NK (1), and unspecified infliximab biosimilars (2). Etanercept publications covered SB4 (2) and GP2015 (2). Adalimumab publications covered ABP 501 (2) and SB5 (1). Rituximab publications covered CT-P10 (1). Efficacy and safety data generally showed no differences between patients who switched treatments versus those who did not. No differences were seen pre- and post-switch. Immunogenicity data were presented in 19/37 (51%) studies. Additional data from switching studies of these therapies are still required, as is continuing pharma-covigilance. Switching should remain a case-by-case clinical decision made by the physician and patient on an individual basis supported by scientific evidence.

Keywords: Biologics; Biosimilars; Clinical trials; Real world data; Switching.

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Conflict of interest statement

Funding

This article was funded by Pfizer. Medical writing support was provided by Lorna Forse, PhD, of Engage Scientific Solutions and was funded by Pfizer.

Conflicts of Interests

Robert Moots has received research grants from Novartis, Pfizer, Roche, and UCB Pharma, personal fees from Chugai, Cellgene, Novartis, and Pfizer, consulting fees from Novartis and Pfizer, and has participated in advisory boards for Pfizer. Valderilio Azevedo has participated in speakers’ bureau for Pfizer, AbbVie, UCB, Janssen, and Bristol Myers-Squibb, and has participated in advisory boards for Pfizer. Javier L. Coindreau is an employee of Pfizer and holds stock in Pfizer. Thomas Dörner has received consulting fees from Pfizer, MSD, UCB, Bioepis, Biogen, Hospira, Roche, Sanofi, J&J, and AbbVie, and has participated in advisory boards for Pfizer, Hospira, MSD, and Amgen. Ehab Mahgoub is an employee of Pfizer and holds stock in Pfizer. Eduardo Mysler has received consulting fees from AbbVie, BMS, Pfizer, Roche, Pharma, GEMMA, and Mabxience, and has participated in advisory boards for Pfizer. Morton Scheinberg has participated in advisory boards for Pfizer. Lisa Marshall is an employee of Pfizer and holds stock in Pfizer.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human participants or animals that have been performed by any of the authors.

Figures

Fig. 1
Fig. 1
Elements of the optimal switching study and study designs employed by switching studies of reference biologics and biosimilars
See this image and copyright information in PMC

References

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