Systematic review: effectiveness and safety of switching between originator infliximab and biosimilar infliximab in patients with inflammatory bowel disease

ABSTRACT

Introduction

Infliximab (IFX) biosimilars are available to treat inflammatory bowel disease (IBD), offering cost reductions versus originator IFX in some jurisdictions. However, concerns remain regarding the efficacy and safety of originator-to-biosimilar switching. This systematic literature review evaluated safety and effectiveness of switching between IFX products in patients with IBD, including multiple switchers.

Methods

Embase, PubMed, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials were searched to capture studies (2012–2022) including patients with IBD who switched between approved IFX products. Effectiveness outcomes: disease activity; disease severity; response to treatment; patient-reported outcomes (PROs). Safety outcomes: incidence and rate of adverse events (AEs); discontinuations due to AEs, failure rate; hospitalizations; surgeries. Immunogenicity outcomes (n, %): anti-drug antibodies; patients receiving concomitant immunomodulatory medication.

Results

Data from 85 publications (81 observational, two randomized controlled trials) were included. Clinical effectiveness outcomes were consistent with the known profile of originator IFX with no difference after switching. There were no unexpected/serious AEs after switching, and rates of AEs were generally consistent with the known profile of IFX.

Conclusions

Most studies reported that clinical, PROs, and safety outcomes for originator-to-biosimilar switching were clinically equivalent to originator responses. Limited data are available regarding multiple switches.

Protocol registration

www.crd.york.ac.uk/prospero identifier is CRD42021289144.

KEYWORDS:

• Biologics
• biosimilars
• Crohn’s disease
• efficacy
• inflammatory bowel disease
• infliximab
• safety, switching
• ulcerative colitis

Acknowledgments

Medical writing support was provided by Sharmila Blows, PhD, of Envision Pharma Group and was funded by Pfizer. The authors thank Karen Smoyer, PhD, of Curo, a division of the Envision Pharma Group, for contributing to the study design, analyzing the data, and organizational contributions to this work, which was funded by Pfizer.

Article highlights

• Despite the growing availability of biosimilars and increasing data on their highly similar clinical profiles (to their respective originators), many healthcare providers still remain skeptical regarding the safety of using biosimilars instead of the originator in bio-naïve patients, as well as switching patients from an originator to a biosimilar.

• A number of longitudinal real-world data indicates that switching from originator IFX to biosimilars is associated with similar effectiveness, safety, and tolerability which continues to support IFX biosimilar use as an alternative to originator for patients with IBD.

• Over the long term, switching from originator to biosimilar IFX had no observed impact on patient-reported outcomes, quality of life or immune response in patients with IBD.

• There is a lack of high-quality randomized controlled trials evaluating biosimilar use in patients with IBD with longer follow-up periods and clearly defined clinical outcomes using formal reporting procedures for endoscopy outcomes, including mucosal healing and fistula closure.

Declaration of interest

GR Lichtenstein has acted as a consultant for AbbVie, American Regent, Cellgene/Bristol Myers Squibb, Eli Lilly, Endo International, Ferring, Fresenius Kabi (Health and Wellness Partners), Gilead, Janssen (now Johnson & Johnson), MedEd Consultants, Pharmacosmos, Pfizer, Prometheus Laboratories, Sandoz, Takeda Pharmaceutical Company, and UCB. Performed CME supported by AbbVie, Allergan, American Gastroenterological Association, American Regent, Annenberg Center for Health Sciences, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Exact Sciences, Ferring, IBD Horizons, Ironwood, Janssen (now Johnson & Johnson), MedEd Consultants, Pennsylvania Society of Gastroenterology, Sanofi, Salix, Seres Pharmaceuticals, Takeda, Vindico. Other finances received: Eli Lilly for DSMB (Honorarium for Data Safety Monitoring Board), Gastro-Hep Communications (Honorarium for executive editor), Janssen Orthobiotech (Finances to Fund GI IBD Fellowship), Pfizer (Finances to Fund GI IBD Fellowship), Professional Communications, Inc- textbook royalty, Springer Science and Business Media- Editor (Honorarium), Up To Date- Walters Kluwer- Author (Honorarium). Research: Takeda, UCB, Bristol Myers Squibb, Janssen (now Johnson & Johnson). BG Feagan has acted as a consultant for AbbVie, AbolerIS Pharma, Agomab Therapeutics, AllianThera Biopharma, Amgen, AnaptysBio, Applied Molecular Transport Inc, Arena Pharmaceuticals, Avoro Capital Advisors, Atomwise, BioJamp, Biora Therapeutics, Boehringer Ingelheim, Boxer Capital, Celsius Therapeutics, Celgene/Bristol Myers Squibb, Connect Biopharma, Cytoki Pharma, Disc Medicine, Duality Biologics, EcoR1, Eli Lilly, Equillium, Ermium Therapeutics, First Wave BioPharma, FirstWord Pharma, Galapagos NV, GalenAtlantica, Genentech/Roche, Gilead Sciences, Gossamer Bio, GSK, Hinge Bio, HotSpot Therapeutics, InDex Pharmaceuticals, Imhotex, Immunic Therapeutics, JAKAcademy, Janssen (now Johnson & Johnson), Japan Tobacco Inc., Kaleido Biosciences, Landos Biopharma, Leadiant Biosciences, L.E.K. Consulting, Lenczner Slaght, LifeSci Capital, Lument AB, Millennium Pharmaceuticals, MiroBio, Morgan Lewis, Morphic Therapeutic, Mylan, OM Pharma, Origo BioPharma, Orphagen Pharmaceuticals, Pandion Therapeutics, Pendopharm, Pfizer, Prometheus Therapeutics and Diagnostics, Play to Know AG, Progenity Pharmaceuticals/Biora Therapeutics, Protagonist Therapeutics, PTM Therapeutics, Q32 Bio, Rebiotix, REDX Pharma, Roche, Sandoz, Sanofi, Seres Therapeutics, Surrozen, Takeda Pharmaceutical Company, Teva Pharmaceuticals, Thelium Therapeutics, TiGenix, Tillotts Pharma UK, Ventyx Biosciences, VHSquared Ltd., Viatris, Ysios Capital, Ysopia Bioscience, and Zealand Pharma. Speaker for AbbVie, Janssen, and Takeda Pharmaceutical Company. S Singh is an employee of Curo, a division of the Envision Pharma Group, which was a paid consultant to Pfizer in connection with the development of this manuscript. A Soonasra and M Latymer are employees of Pfizer and hold stock or stock options in Pfizer. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Data availability statement

All data generated or analyzed during this study are included in this published article or as supplementary information files.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14712598.2024.2378090

Additional information

Funding

This study was funded by Pfizer.