Therapeutic drug monitoring is of particular importance in optimizing treatment for patients with inflammatory bowel disease (IBD) who are receiving therapy with anti–tumor necrosis (anti-TNF) drugs like adalimumab. This week, during the United European Gastroenterology (UEG) Week 2019 meeting, held in Barcelona, Spain, researchers will present new findings on monitoring serum trough levels of Samsung Bioepis’ biosimilar adalimumab, Imraldi, in patients with IBD.
Therapeutic drug monitoring is of particular importance in optimizing treatment for patients with inflammatory bowel disease (IBD) who are receiving therapy with anti—tumor necrosis (anti-TNF) drugs like adalimumab. This week, during the United European Gastroenterology Week 2019 meeting, held in Barcelona, Spain, researchers will present new findings on monitoring serum trough levels of Samsung Bioepis’ biosimilar adalimumab, Imraldi, in patients with IBD.
First, a research team from the Czech Republic will present data from a study in 87 patients with IBD, 77 of whom had Crohn disease (CD) and 10 of whom had ulcerative colitis (UC) who were switched from the reference adalimumab, Humira, to the biosimilar.1 These patients all had 3 previous measurements of adalimumab trough levels from their treatment with the originator drug, and their biosimilar adalimumab trough levels were measured at week 10 after the switch using an adalimumab-validated ELISA assay.
The researchers report that there was “excellent” quantitative agreement between adalimumab trough levels before and after the switch to the biosimilar (Spearman’s rank coefficient values, R = .756, P <.0001).
Moreover, there were no differences in C-reactive protein or fecal calprotectin values before and after the switch, and no significant differences in disease activity scores using the Harvey-Bradshaw Index or partial Mayo score.
Another research team, also from the Czech Republic, will report on the use of 2 different monitoring assays—a TNF-based ELISA kit and a monoclonal antibody-based ELISA kit—for monitoring trough levels of the biosimilar.2
The research team obtained 62 samples of sera from patients (54 of whom had CD and 8 of whom had UC) who were receiving maintenance therapy with Imraldi at a dose of 40 mg every 2 weeks. Adalimumab trough levels were measured by both the standard TNF-based assay and by the monoclonal antibody assay, and the data were analyzed, with a Kruskal-H test used to compare the 2 cohorts of concentration values.
The researchers report that quantitative agreement was observed between the 2 measurement kits (R = .804, P <.0001), and the non-parametric Kruskal Wallis test showed that the median tough level concentrations did not differ (P =.363), and they add that these data should be valuable in determining the potential to use the kits as tools for drug monitoring during biosimilar adalimumab treatment.
These new data, said Ian Henshaw, vice president and head of the global biosimilars unit at Biogen, which together with Samsung BioLogics comprises Samsung Bioepis, are part of continued research “with the goal of generating data that will enable us to deliver value to patients with high unmet needs.”
References
1. Lukas M, Pesinová V, Bortlik M, et al. Impact of the switch from original adalimumab to biosimilar adalimumab SB5 on serum drug trough levels, clinical and biological disease activity in patients with IBD. Presented at: United European Gastroenterology Week 2019; October 29-23, 2019; Barcelona, Spain.
2. Malícková K, Bortlík M, Duricová D, et al. Serum trough SB5 levels: A comparison of two different immunoassays for the monitoring of biosimilar adalimumab treatment in patients with inflammatory bowel disease. Presented at: United European Gastroenterology Week 2019; October 29-23, 2019; Barcelona, Spain.
Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo
November 7th 2024For the first time, Skyrizi (risankizumab-rzaa) has replaced Humira (reference adalimumab) as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Eye on Pharma: Henlius, Organon Updates; Meitheal Portfolio Expansion; Celltrion Zymfentra Data
November 5th 2024Henlius and Organon’s pertuzumab biosimilar met phase 3 goals; Meitheal expanded its US biosimilars; Celltrion’s subcutaneous infliximab (Zymfentra) showed monotherapy could be as effective as combination therapy for inflammatory bowel disease.
Biosimilars Gastroenterology Roundup for May 2024—Podcast Edition
June 2nd 2024On this episode of Not So Different, we review the biggest gastroenterology biosimilar stories from May 2024, covering new data from conferences and journals on infliximab and adalimumab products that demonstrate positive clinical results and confirm the safety of these biosimilars, as well as the feasibility of switching to them.
Panelists Stress Stakeholder Education to Build Confidence in Biosimilars
October 31st 2024By expanding educational initiatives to clarify biosimilar safety, efficacy, and interchangeability, stakeholders can foster trust, improve access, and ensure that biosimilars are widely accepted as high-quality, cost-effective alternatives to originator biologics.
Competitive Pricing in Biosimilars: How Adalimumab Could Shape the Industry
Published: October 29th 2024 | Updated: October 29th 2024Sophia Humphreys, PharmD, MHA, BCBBS, of Sutter Health notes that although initial adoption of adalimumab biosimilars remained low in 2023, competitive pricing pressures have already benefited patients and the health care sector.