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Review
. 2025 Feb 26;14(5):1561.
doi: 10.3390/jcm14051561.

Accelerating Earlier Access to Anti-TNF-α Agents with Biosimilar Medicines in the Management of Inflammatory Bowel Disease

Gionata Fiorino  1 , Ashwin Ananthakrishnan  2 , Russell D Cohen  3 , Raymond K Cross  4 , Parakkal Deepak  5 , Francis A Farraye  6 , Jonas Halfvarson  7 , A Hillary Steinhart  8
Affiliations
Review

Accelerating Earlier Access to Anti-TNF-α Agents with Biosimilar Medicines in the Management of Inflammatory Bowel Disease

Gionata Fiorino et al. J Clin Med. .

Abstract

Data indicate that earlier initiation of anti-tumor necrosis factor alpha (anti-TNF-α) biologic medicines may prevent progression to irreversible bowel damage and improve outcomes for patients with inflammatory bowel disease (IBD), particularly Crohn's disease. However, the high cost of such therapies may restrict access and prevent timely treatment of IBD. Biosimilar anti-TNF-α medicines may represent a valuable opportunity for cost savings and optimized patient outcomes by improving access to advanced therapies and allowing earlier anti-TNF-α treatment initiation. Biosimilar anti-TNF-α medicines have been shown to offer consistent therapeutic outcomes to their reference medicines, yet despite entering the IBD treatment armamentarium over 10 years ago, their implementation in clinical practice remains suboptimal. Factors limiting the 'real' use of biosimilar anti-TNF-α medicines may include an ongoing lack of understanding and acceptance of biosimilars by both healthcare professionals (HCPs) and patients, as well as systemic factors such as formulary decisions outside of the control of the prescriber. In this review, an expert panel of gastroenterologists discusses HCP-level considerations to improve biosimilar anti-TNF-α utilization in IBD in order to support early anti-TNF-α initiation and maximize patient outcomes.

Keywords: Crohn’s disease; anti-TNF-?; biosimilar; early treatment; inflammatory bowel disease; ulcerative colitis.

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Conflict of interest statement

Gionata Fiorino has served as a consultant and advisory board member for AbbVie, Takeda, Janssen, Pfizer, Celltrion, Sandoz, Galapagos, STADA, and Ferring. Ashwin Ananthakrishnan has no relevant conflicts of interest to disclose. Russell Cohen has served as a speaker and/or consultant/advisory board member for AbbVie, BMS/ Celgene, Eli Lilly, Genentech, Gilead Sciences, Hoffmann La-Roche, Janssen, Pfizer, Sandoz, Takeda, and UCB Pharma. Raymond Cross has participated in consulting and advisory boards for AbbVie, Adiso, BMS, Fzata, Fresenius Kabi, Janssen, Magellan Health, Option Care, Pfizer, Pharmacosmos, Samsung Bioepis, Sandoz, Sebela, and Takeda. He is a member of the Executive Committee for the IBD Education Group and is Scientific Co-Director of the CorEvitas Registry. He has a research grant with Janssen. He has taken part in speakers’ bureaus for BMS and Pfizer. Parakkal Deepak has served as a consultant and/or advisory board member for Janssen, Pfizer, Prometheus Biosciences, Boehringer Ingelheim, AbbVie, and Sandoz. He has also received funding under a sponsored research agreement unrelated to the data in the paper from Janssen, Teva Pharmaceuticals, Landos Pharma, Agomab, Takeda Pharmaceutical, Pfizer, Bristol Myers Squibb-Celgene, and Boehringer Ingelheim. Francis Farraye has served as a consultant and/or advisory board member for AbbVie, Avalo Therapeutics, BMS, Braintree Labs, Fresenius Kabi, GI Reviewers, GSK, IBD Educational Group, Iterative Health, Janssen, Pharmacosmos, Pfizer, Sandoz Immunology, Sebela, and Viatris. He is a member of the data safety monitoring board for Eli Lilly. Jonas Halfvarson has served as speaker and/or advisory board member for AbbVie, Alfasigma, Aqilion, BMS, Celgene, Celltrion, Dr Falk Pharma and the Falk Foundation, Eli Lilly, Ferring, Galapagos, Gilead, Hospira, Index Pharma, Janssen, MEDA, Medivir, Medtronic, MSD, Novartis, Pfizer, Prometheus Laboratories Inc., Sandoz, Shire, STADA; Takeda, Thermo Fisher Scientific, Tillotts Pharma, Vifor Pharma and UCB, and received grant support from Janssen, MSD and Takeda. A. Hillary Steinhart has served on advisory boards or speakers’ bureaus for AbbVie, Amgen, BioJAMP, BMS, Fresenius Kabi, Janssen, McKesson, Organon, Pendopharm, Pfizer, Sandoz, Takeda, Viatris (Biocon), has received grant support from Arena (Pfizer), AbbVie, Celgene (BMS), Genentech/Roche, Janssen and Takeda, and has been a consultant for NKS Pharmacy.

Figures

Figure 1
Figure 1
Conceptual framework for optimizing biosimilar anti-TNF-α use in IBD. HCP, healthcare professional; IBD, inflammatory bowel disease; TNF-α, tumor necrosis factor alpha [51].
See this image and copyright information in PMC

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